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Showing 6621–6640 of 8389 results

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HE 600 System (Ventana) – Potential Fluid Leak Fire Risk (2022)

There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

FDAJun 1, 2022AL, AZ, AR +37 more• Ventana Medical Systems Inc

epoc BGEM Test Card (Siemens) – Potential Oxygen Result Bias (2022)

Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

FDAJun 1, 2022AL, CA, CO +7 more• Siemens Healthcare Diagnostics Inc

Philips Laser System (Spectranetics) – Hardware Detection Issue (2022)

The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.

FDAJun 1, 2022AZ, AR, CA +24 more• Spectranetics Corporation

NaviCare Nurse Call (Baxter) – Wireless Integration Issue (2022)

An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.

FDAMay 31, 2022Nationwide• Baxter Healthcare Corporation

GreenLight HPSEA Laser Fibers (Boston Scientific) – Fiber Type Mismatch (2022)

Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

FDAMay 31, 2022AR, CA, IL +4 more• Boston Scientific Corporation

Xhibit Telemetry Receiver (Spacelabs) – Alarm Escalation Defect (2022)

Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

FDAMay 31, 2022Nationwide• Spacelabs Healthcare, Inc.

NaturaLyte Liquid Acid (Fresenius) – Alternate Cap Problem (2022)

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

NaturaLyte Liquid Acid (Fresenius) – Alternate Cap Problem (2022)

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Avance CS2 Anesthesia System (GE Healthcare) – Base Crack Risk (2022)

The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

FDAMay 27, 2022AZ, CA, CO +25 more• GE Healthcare, LLC

Anti-SARS-CoV-2 IgG Reagent (Ortho-Clinical) – On-Analyzer Stability Issue (2022)

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

FDAMay 26, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

HammerTube Implant (Paragon 28) – Coating Missing (2022)

Due to Titanium plasma coating not present implant.

FDAMay 26, 2022Nationwide• Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062

a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOIS... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) M... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/C... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medlin... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) C... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Fertility Test Kit (McKesson) – Temperature Exposure Risk (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Coag-Sense Professional Test (Rapid Test) – Temperature Exposure Risk (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # ... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

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