Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Giraffe OmniBed Carestation CS1 - Product Usage: The device can Recalled by GE Healthcare, LLC Due to Fasteners potentially torqued to a value less than...

Date: July 26, 2019
Company: GE Healthcare, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.

Affected Products

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

Quantity: 59 devices (50 US, 9 OUS)

Why Was This Recalled?

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report