Reported Jun 24, 2020 · Terminated
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
- Lot codes and dates
- Giraffe Incubatorserial numbers HDGA through HDGQ
- Servo Oxygen Board spare part kit6600-0233-850
- Servo Oxygen upgrade kits
6600-0678-8006600-0678-8016600-0678-8026600-0678-80366000849-8006600-0849-8016600-0849-8026600-0849-8036600-0866-8006600-0866-8016600-08678006600-0867-801M1142293 or M1142295
- Amount recalled
- 5,883 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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