Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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LEICA BIOSYSTEMS NUSSLOCH GMBH
Class I - Dangerous
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Apr 10, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Dec 8, 2023 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
Apr 11, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Remote Diagnostic Technologies
Class I - Dangerous
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
May 9, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024 Other Medical Devices Nationwide
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