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Showing 6021–6040 of 11714 results

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Exactech Optetrak Knee System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

FDANov 21, 2023AR, FL, GA +13 more• Exactech, Inc.

Exactech Optetrak Logic Knee System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

FDANov 21, 2023AR, FL, GA +13 more• Exactech, Inc.

Exactech Vantage Ankle System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Moderate

FDANov 21, 2023AR, FL, GA +13 more• Exactech, Inc.

Exactech AcuMatch Hip System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

FDANov 21, 2023AR, FL, GA +13 more• Exactech, Inc.

NovoTHOR Light Pod (THOR) – Gas Strut Ball Stud Failure (2023)

One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy

FDANov 20, 2023AZ, CA, CO +14 more• THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom

AirFit F20 Full Face Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

AirFit N10 Nasal Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

AirFit F30i Full Face Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

Calibration Serum Level 3 (Randox) – CK Total Bias (2023)

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Olympus EndoEye Flex Videoscope – Reprocessing Deviation (2023)

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

FDANov 20, 2023Nationwide• Olympus Corporation of the Americas

AirTouch N20 Nasal Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

AirTouch F20 Full Face Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

Leica HistoCore PEGASUS (Leica) – Tissue Processing Issue (2023)

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

FDANov 20, 2023Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Calibration Serum Level 3 (Randox) – Alkaline Phosphatase Misassignment (2023)

Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

AirFit F30 Full Face Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

AirFit N20 Nasal Mask – Magnetic Interference (2023)

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

FDANov 20, 2023Nationwide

KeySplint Hard Clear (Keystone) – Incorrect Instructions (2023)

Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

FDANov 20, 2023Nationwide• Keystone Industries

GENOSYL DS Cassette (Vero Biotech) – Flow Criterion Issue (2023)

Cassette did not meet an 1n-process flow criterion.

FDANov 17, 2023AZ, FL• Vero Biotech, LLC

Panorama MR System (Philips) – Helium Pressure Buildup (2023)

Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.

FDANov 17, 2023AL, AZ, CA +31 more• Philips North America Llc

Atlan Gas Machine (Draegerwerk) – Battery Failure Risk (2023)

Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

FDANov 17, 2023IN• Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee

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