Recall

All recalls8,501 total

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Philips North America — Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips Healthcare (Suzhou) Co., Ltd. — Philips Incisive CT

Potential for incomplete scan due to unstable connection inside of floating sensor.

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Philips North America — Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

C
CareFusion 303, Inc. — BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 13

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

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Medtronic Neuromodulation — A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT9

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

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Philips North America — Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Philips North America — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

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Fazt & Loud LLC — Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged

Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Microbiologics Inc — KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

M
Microbiologics Inc — KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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Microbiologics Inc — LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Z
Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 m

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatme

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Descriptio

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 202

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Descri

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, Ra

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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RAYSEARCH LABORATORIES AB — RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3.

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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Baxter Healthcare Corporation — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

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