Medical device recalls Moderate risk

GE Healthcare, LLC recalls Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Caresta…

Recall date
September 25, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0479-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
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, Pakist…

Why it was recalled

Potential electric leakage affecting the user.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

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