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.
Recall
- Recall Number
- Z-0281-2020
- Event Number
- 83532
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- FMZ
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 26, 2019
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
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.
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
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, but provided an updated list of affected serial numbers.
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.
59 devices (50 US, 9 OUS)