Home / Recalls / Medical Devices
GE Healthcare, LLC recalls Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestat
Recalled November 28, 2018 · FDA recall Z-0479-2019 · GE Healthcare
Hazard
Potential electric leakage affecting the user. · FDA Class II
Units
1,724 devices total
Sold at
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, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Description
Potential electric leakage affecting the user.
Product
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →