The Recall Desk
HighFDA (Devices)·Z-2102-2023·Announced 2023-07-12

Giraffe OmniBed bedside panel kits recalled for incorrect secondary latch

GE HealthCare is recalling Beside panel field replacement unit kits for Giraffe OmniBed devices due to potential incorrect secondary latch installation on northeast and northwest 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 without reported injuries or illnesses. Secondary latch defect on a neonatal care device represents a risk of harm, meeting the criteria for High severity.

Plain-English summary

GE HealthCare is recalling Beside panel Field Replacement Unit (FRU) kits for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices. These kits are replacement components for bedside panels on neonatal care equipment. Approximately 18 units have been identified across model numbers 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34, and 5865387-01 to 5865387-34.

An incorrect type of secondary latch may have been installed on the northeast and/or northwest bedside panels of affected devices. The secondary latch is a component that helps secure and stabilize the bedside panel assembly. Installation of an incorrect latch type could compromise the panel's functionality and stability.

The affected field replacement unit kits have been distributed worldwide for use in healthcare facilities.

The recalled product

Product
Beside panel FRU (Field Replacement Units) Kits
Manufacturer
DATEX--OHMEDA, INC.
Category
Medical Device — Neonatal Care Equipment
Hazard
Affected units
18

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 (3)

  • Models: 5865384-01 to 5865384-34
  • 5865385-01 to 5865385-34
  • 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34

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.

See all →

Same hazard · latch failure

See all →