Recall Z-0479-2019 ยท FMZ Incubator, Neonatal
GE Healthcare, LLC
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
| Date | Sep 25, 2018 |
| Status | Terminated |
| Reason | Potential electric leakage affecting the user. |
| Root cause | Process design |
| Action | GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electri |
| Quantity | 1,724 devices total |
| Distribution | Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakista |
| 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 |