Recall

All recalls7,814 total

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/20 OR Table; System Code: 722039;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/15; System Code: 722058;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/20; System Code: 722038;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD10C; System Code: 722001;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Q

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

W
Wilson-Cook Medical Inc. — Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

A
Angiodynamics, Inc. — AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Q

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Bo

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pou

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H78710714024

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch);

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); B

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

A
Angiodynamics, Inc. — Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouc

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/15 OR Table; System Code: 722059;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M12; System Code: (1)722227, (2)722231;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

O
Oxoid Australia Pty Limited — OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10F; System Code: 722002;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20/10; System Code: 722029;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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