Recall

All recalls7,819 total

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Philips North America Llc — IntelliVue Patient Monitor MX800. Product Number: 865240.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP90. Product Number: M8010A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP30. Product Number: M8002A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips Ultrasound, LLC — Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

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Philips North America Llc — IntelliVue Patient Monitor MX700. Product Number: 865241.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX500. Product Number: 866064.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX850. Product Number: 866470.

Potential issue where the IntelliVue monitors did not alarm.

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Stryker Corporation — NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

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Stryker Corporation — NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-80

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

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Philips North America Llc — IntelliVue MP2. Product Number: M8102A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP50. Product Number: M8004A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP80. Product Number: M8008A.

Potential issue where the IntelliVue monitors did not alarm.

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Aizu Olympus Co., Ltd. — Olympus OER-Elite

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

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Aizu Olympus Co., Ltd. — Olympus OER-Mini

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

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Philips North America Llc — IntelliVue Patient Monitor MX100. Product Number: 867033.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP40. Product Number: M8003A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP60. Product Number: M8005A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP5. Product Number: M8105A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP20. Product Number: M8001A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX600. Product Number: 865242.

Potential issue where the IntelliVue monitors did not alarm.

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Stryker Medical Division of Stryker Corporation — Stryker Arise 1000EX mattress, Part Number 2236000000

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

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Stryker Medical Division of Stryker Corporation — Stryker MV3 bariatric bed, Part Number 5900000001

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

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Philips North America Llc — IntelliVue Patient Monitor MX400. Product Number: 866060.

Potential issue where the IntelliVue monitors did not alarm.

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Aizu Olympus Co., Ltd. — Olympus OER-Pro

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

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Philips North America Llc — IntelliVue Patient Monitor MX550. Product Number: 866066.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX750. Product Number: 866471.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX450. Product Number: 866062.

Potential issue where the IntelliVue monitors did not alarm.

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Stryker Corporation — NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

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Philips North America Llc — IntelliVue MP70. Product Number: M8007A.

Potential issue where the IntelliVue monitors did not alarm.

C
Cepheid — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

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Olympus Corporation of the Americas — Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

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Cepheid — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

I
Inpeco S.A. — FlexLab (FLX); Version: FLX-217-40;

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes

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