Beside panel FRU (Field Replacement Units) Kits
This recall is currently active, issued July 6, 2023. It was issued by Datex--Ohmeda, Inc..
- Company
- Datex--Ohmeda, Inc.
- Recall Initiated
- May 19, 2023
- Posted
- July 6, 2023
- Recall Number
- Z-2102-2023
- Quantity
- 18
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide distribution.
Lot / Code Info
Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34
Root Cause
Nonconforming Material/Component
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.