The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2100-2023·Announced 2023-07-12

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer
DATEX--OHMEDA, INC.
Category
Medical Device — Neonatal warmer
Hazard
Affected units
4,540

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.

Part of a larger recall action

This product is one of 3 recalled by DATEX--OHMEDA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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