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)ANAK
224 of 224 codes
5395419-15395419-25395419-354053655391200-15391200-105391200-115391200-125391200-25391200-35391200-45391200-55391200-65391200-75391200-85391200-954021825393755-15393755-25403569-15403569-105403569-115403569-125403569-135403569-25403569-35403569-45403569-55403569-65403569-75403569-85403569-95403570-15403570-25403570-35403570-45403570-55392643-15392643-105392643-115392643-125392643-135392643-25392643-35392643-45392643-55392643-65392643-75392643-85392643-95393856-15393856-105393856-115393856-125393856-135393856-145393856-155393856-25393856-35393856-4
964 of 964 codes
00930ANAK00927ANAK00928ANAK00929ANAK00931ANAK00932ANAK00933ANAK00934ANAK00935ANAK00936ANAK00937ANAP00607ANAP00608ANAQ00896ANAQ00897ANAQ00898ANAQ008995393947-15393947-105393947-115393947-125393947-135393947-145393947-155393947-165393947-175393947-185393947-195393947-25393947-205393947-215393947-225393947-235393947-245393947-255393947-265393947-275393947-285393947-295393947-35393947-305393947-315393947-325393947-335393947-345393947-355393947-365393947-375393947-385393947-395393947-45393947-405393947-415393947-425393947-435393947-445393947-455393947-465393947-55393947-6
- ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in device. Device serial number to be provided later)
- 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.
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