Reported Apr 20, 2016 · Terminated

GE Healthcare, Aisys Carestation.

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 Carestation.
Lot codes and dates
  • ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in device. Device serial number to be provided later)

    224 of 224 codes

    • 5395419-1
    • 5395419-2
    • 5395419-3
    • 5405365
    • 5391200-1
    • 5391200-10
    • 5391200-11
    • 5391200-12
    • 5391200-2
    • 5391200-3
    • 5391200-4
    • 5391200-5
    • 5391200-6
    • 5391200-7
    • 5391200-8
    • 5391200-9
    • 5402182
    • 5393755-1
    • 5393755-2
    • 5403569-1
    • 5403569-10
    • 5403569-11
    • 5403569-12
    • 5403569-13
    • 5403569-2
    • 5403569-3
    • 5403569-4
    • 5403569-5
    • 5403569-6
    • 5403569-7
    • 5403569-8
    • 5403569-9
    • 5403570-1
    • 5403570-2
    • 5403570-3
    • 5403570-4
    • 5403570-5
    • 5392643-1
    • 5392643-10
    • 5392643-11
    • 5392643-12
    • 5392643-13
    • 5392643-2
    • 5392643-3
    • 5392643-4
    • 5392643-5
    • 5392643-6
    • 5392643-7
    • 5392643-8
    • 5392643-9
    • 5393856-1
    • 5393856-10
    • 5393856-11
    • 5393856-12
    • 5393856-13
    • 5393856-14
    • 5393856-15
    • 5393856-2
    • 5393856-3
    • 5393856-4
    ANAK

    964 of 964 codes

    • 00930
    • ANAK00927
    • ANAK00928
    • ANAK00929
    • ANAK00931
    • ANAK00932
    • ANAK00933
    • ANAK00934
    • ANAK00935
    • ANAK00936
    • ANAK00937
    • ANAP00607
    • ANAP00608
    • ANAQ00896
    • ANAQ00897
    • ANAQ00898
    • ANAQ00899
    • 5393947-1
    • 5393947-10
    • 5393947-11
    • 5393947-12
    • 5393947-13
    • 5393947-14
    • 5393947-15
    • 5393947-16
    • 5393947-17
    • 5393947-18
    • 5393947-19
    • 5393947-2
    • 5393947-20
    • 5393947-21
    • 5393947-22
    • 5393947-23
    • 5393947-24
    • 5393947-25
    • 5393947-26
    • 5393947-27
    • 5393947-28
    • 5393947-29
    • 5393947-3
    • 5393947-30
    • 5393947-31
    • 5393947-32
    • 5393947-33
    • 5393947-34
    • 5393947-35
    • 5393947-36
    • 5393947-37
    • 5393947-38
    • 5393947-39
    • 5393947-4
    • 5393947-40
    • 5393947-41
    • 5393947-42
    • 5393947-43
    • 5393947-44
    • 5393947-45
    • 5393947-46
    • 5393947-5
    • 5393947-6
Amount recalled
1294

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.

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.

Free recall alerts

Get alerted about new GE Medical Systems, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 5:20 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.