Recall Z-0281-2020— GE Healthcare, LLC

Name: FDA recall Z-0281-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-07-26. It names one FDA 510(k) clearance: K152814. Product: 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.. Reason: Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-07-26
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K152814 — Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company·cleared 2016-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.