DATEX--OHMEDA, INC. Beside panel FRU (Field Replacement Units) Kits Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beside panel FRU (Field Replacement Units) Kits
Brand
DATEX--OHMEDA, INC.
Lot Codes / Batch Numbers
Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34
Products Sold
Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34
DATEX--OHMEDA, INC. is recalling Beside panel FRU (Field Replacement Units) Kits due to 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 north. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026