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Showing 8301–8320 of 35916 results

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Equate Eye Ointment (Brassica) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

Epix Universal Clip Applier (Applied Medical) – Clip Loading Issue (2024)

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

FDAJan 30, 2024Nationwide• Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Moderate

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

NxStage Cartridge Express (NxStage) – Blood Leakage Risk (2024)

Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.

FDAJan 29, 2024AZ, CA, CO +16 more• NxStage MDS Corporation

Soltive Laser (Olympus) – Non-Compliant Power Cord (2024)

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

FDAJan 29, 2024IN• Olympus Corporation of the Americas

Vantage Elan MRI (Canon) – SFG Value Mismatch (2024)

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

Vantage MRI Systems (Canon) – SFG Value Mismatch (2024)

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Soltive Pro Laser (Olympus) – Non-Compliant Power Cord (2024)

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

FDAJan 29, 2024IN• Olympus Corporation of the Americas

Vantage Titan MRI (Canon) – SFG Value Mismatch (2024)

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

IdentiTi ALIF System (Alphatec) – Graft Bolt Breakage (2024)

Due to reports of intraoperative graft bolt implantation breakages.

FDAJan 26, 2024Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

VITROS XT 3400 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Blue Bird Vision Transit Bus (Blue Bird) – Parking Brake Issue (2024)

Blue Bird Body Company (Blue Bird) is recalling certain 2024 Vision buses. The parking brake secondary release mechanism may malfunction and allow the lever to be released without pressing the release button.

NHTSAJan 26, 2024Nationwide• BLUE BIRD

Coachmen Prism (Coachmen) – Furnace Overheat Risk (2024)

Forest River, Inc. (Forest River) is recalling certain 2023-2024 Coachmen Prism Class C motorhomes. The furnace may overheat and cause a crack in the burn chamber, which can allow carbon monoxide to enter the cabin.

NHTSAJan 26, 2024Nationwide• COACHMEN

BCID2 Panel (BioFire) – False Positive Results (2024)

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

Schiff Reagent (EMD Millipore) – Unexpected Color (2024)

This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.

FDAJan 26, 2024AL, IL, MA +5 more• EMD Millipore Corporation

FilmArray GI Panel (BioFire) – False Norovirus Results (2024)

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

VITROS 3600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 5600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

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