Giraffe OmniBed neonatal devices recalled due to incorrect secondary latch
GE HealthCare is recalling approximately 4,540 Giraffe OmniBed and Giraffe OmniBed Carestation neonatal warming devices worldwide due to potentially incorrect secondary latches on bedside panels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a structural defect in a neonatal care device with no reported injuries or hospitalizations. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE HealthCare is recalling certain models of the Giraffe OmniBed and Giraffe OmniBed Carestation neonatal devices. The recall was initiated because an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels. These devices are used in hospital neonatal intensive care units and similar medical settings.
Approximately 4,540 units are affected and have been distributed worldwide. The recall notice identifies specific model numbers and serial numbers to help healthcare facilities determine if their equipment is included.
The secondary latch is a component of the bedside panel fastening system. If an incorrect latch was installed, it could affect the panel's structural integrity and proper operation. Healthcare providers with affected devices should consult the full recall notice for identification and guidance.
The recalled product
- Product
- Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATI
- Manufacturer
- DATEX--OHMEDA, INC.
- Category
- Medical Device — Neonatal warmer
- Hazard
- structural-defect
- equipment-malfunction-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. Model Number 2082844-001-XXX
- GTIN Numbers: 010084068211686221
- 010084068211686221
- All Lot/Serial Numbers. b. Model Number 2074920-001-XXXXXX
- No GTIN Number
- Serial Numbers: HDGR52137
- HDGL50099
- HDGT60164
- HDGT60143
- HDGT60142
- HDGT60139
- HDGT60138
- HDGT60137
- HDGU60753
- HDGT60652
- HDGU60069
- HDGT60141
- HDGU60156
- HDGU60120
- HDGU60119
Distribution
Distribution scope not specified by the agency.
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