Beside panel FRU (Field Replacement Units) Kits
FDA device recall Z-2102-2023 · posted 2023-07-06 · Open, Classified
Recall details
- Recalling firm
- DATEX--OHMEDA, INC.
- Reason for recall
- GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
- Action taken
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees beginning on 05/19/2023 by mail. The notice explained the problem, risk, and requeested the following: Actions to be taken by Customer/User: Inspect the device bedside panels; if the device has the correct latches, continue to use the device. If the device does not have the correct latches, quarantine the device. Inspect any field replaceable bedside panel stock and quarantine for the affected product. GE Healthcare will replace affected latches.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FMZ
- Quantity affected
- 18
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-05-19
- Date posted
- 2023-07-06
- Location
- Wauwatosa, WI
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