The Recall Desk
HighFDA (Devices)·Z-2101-2023·Announced 2023-07-12

Giraffe OmniBed neonatal incubator recall due to incorrect secondary latch installation

GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.

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 of a neonatal incubator with potential structural latch defect. No illnesses or injuries reported. Classified as a risk-of-harm medical device where injury has not yet been reported, per the rubric.

Plain-English summary

GE HealthCare is recalling certain Giraffe OmniBed neonatal incubators because an incorrect type of secondary latch may have been installed on the northeast and/or northwest bedside panels. This recall includes multiple model numbers and configurations in the Giraffe OmniBed and Giraffe OmniBed Carestation product lines.

The secondary latches affected by this recall are on specific bedside panel locations. The potential issue was identified by GE HealthCare, which initiated the recall to address the concern.

A total of 3,053 units are affected by this Class II recall. The devices were distributed worldwide across all lot and serial numbers. Healthcare facilities and organizations using Giraffe OmniBed devices should contact GE HealthCare for further information regarding the incorrect latches and appropriate remedial actions.

The recalled product

Product
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
Manufacturer
DATEX--OHMEDA, INC.
Category
Medical Device — Neonatal Incubator
Hazard
Affected units
3,053

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 (1)

  • All Lot/Serial Numbers

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 →

Related recalls

Same manufacturer · DATEX--OHMEDA, INC.

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Same hazard · latch defect

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