Z-2101-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,053 units
Product Description
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal
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 Pattern
Worldwide distribution.
Code Information
All Lot/Serial Numbers