Reported Apr 20, 2016 · Terminated

GE Healthcare, Aisys CS2 anesthesia..

GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • GE Healthcare, Aisys CS2 anesthesia..
Lot codes and dates
  • 2,964 of 2,964 codes

    • APWU00723
    • APWU00724
    • APWU01057
    • APWU01058
    • APWU01059
    • APWU02682
    • APWU02683
    • APWU02684
    • APWU02685
    • APWU02686
    • APWU02687
    • APWU02688
    • APWU02689
    • APWU02690
    • APWU02691
    • APWU02692
    • APWU02693
    • APWU02694
    • APWU02695
    • APWU01240
    • APWU01241
    • APWU01242
    • APWU01243
    • APWU01244
    • APWU01785
    • APWU01827
    • APWU01988
    • APWU01989
    • APWU01990
    • APWU01991
    • APWU01992
    • APWU01993
    • APWU01994
    • APWU01995
    • APWU01996
    • APWU01997
    • APWU02708
    • APWT02996
    • APWT02384
    • APWT02254
    • APWT02255
    • APWT02256
    • APWT02257
    • APWT02258
    • APWT03126
    • APWT03127
    • APWT02326
    • APWU02707
    • APWT00391
    • APWT00392
    • APWT00393
    • APWT00394
    • APWT00395
    • APWU01576
    • APWU01577
    • APWU01578
    • APWU00363
    • APWU00364
    • APWU00365
    • APWU00366
    A
Amount recalled
5496

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

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 4, 2018 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.