Reported Jul 27, 2022 · Terminated
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
- Lot codes and dates
- Aisys CS2 - GTIN 00840682102292
- Serial numbers starting with APWA
00101 through 0017600185 through 0069700700 through 0076300768 through 0101301016 through 0121601218 through 0122301225 through 0159601601 through 0168301685 through 0180501808 through 0196001964 through 0199902003 through 0202102026 through 021680217502182 through 0230802311 through 0236102376 through 0240502424 through 0242902450 through 0245602519 through 0253102533 through 02539
- Serial numbers starting with APWB
00101 through 001510015400155001620016300169 through 0019900201 through 0033600338 through 0037300378 through 0064400647 through 0068400686 through 0068900691 through 0074300746 through 0075000754 through 0075600770 through 0081800823 through 0082800838 through 0084200905 through 0093100944 through 00952
- Serial numbers starting with APWZ
03034 through 0303703053 through 030560306003062 through 0306603071 through 0307503164 through 0317103311 through 03314033190332003381 through 0341503420 through 03422
- Avance CS2 and Avance CS2 Pro - GTIN00840682102322
- Serial numbers starting with APKA
00101 through 0010500107 through 0016500167 through 0017600178 through 0021800220 through 0076700776 through 0083600838 through 0108101084 through 0115001152 through 0146701469 through 0153201537 through 0154101543 through 0180901811 through 0189401921 through 0196101965 through 0198502009 through 0201302016 through 02029
- Serial numbers starting with APKB00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569
- Amount recalled
- 5,372 devices
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
- Nationwide
Why it was recalled
Stop using this product now
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Using this product could cause serious injury, illness or death — stop using it now.
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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