Recall Z-0281-2020 ยท FMZ Incubator, Neonatal
GE Healthcare, LLC
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.
| Date | Jul 26, 2019 |
| Status | Open, Classified |
| Reason | Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare notified customers on about 07/26/2019 via phone calls and a "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to immediately stop use of and segregate the affected devices, that GE Healthcare would correct all affected products at no cost, and a GE Healthcare representative will contact them to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. A second customer letter was sent on 08/05/2019 to all customer. The second letter contained the same instructions, |
| Quantity | 59 devices (50 US, 9 OUS) |
| Distribution | Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152814 | Giraffe OmniBed Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company, Mar 17, 2016 |