Reported Nov 11, 2020 · Ongoing
Flow Sensor Service Part, Catalog 2089610-001-S
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?
- Flow Sensor Service Part, Catalog 2089610-001-S
- Lot codes and dates
- Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible
- with the following device modelsAespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)
- Amount recalled
- 4794 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Flow sensors could have damaged tubes in the form of small punctures or cuts.
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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