Reported Oct 6, 2021 · Ongoing
Flow sensors that may be installed in the following GEHC anesthesia machines
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 sensors that may be installed in the following GEHC anesthesia machines
13 of 13 products
| Model / number | Product as published |
|---|---|
0080682102339 | (1) Aestiva MRI |
| — | (2) Aestiva 7900 |
| — | (3) Aestiva 7100 |
| — | (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100) |
| — | (5) S/5 Aespire 7900 |
| — | (6) Aespire View |
| — | (7) Avance |
00840682102292 | (8) Avance CS2 |
| — | (9) Aisys |
00840682102322 | (10) Aisys CS2 |
| — | (11) Amingo |
| — | (12) 9100 NXT Config, Aelite NXT |
| — | (13) Protiva 7100 |
- Lot codes and dates
- The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
- Amount recalled
- Estimated 310,072 flow sensors
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
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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