Reported Nov 21, 2018 · Terminated
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS…
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?
- Aisys CS2 Anesthesia System
- Sold under the following product namesAISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE
- Product UsageThe GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment
- Lot codes and dates
- Model Number, UDI Number, (Serial
- Number)
1,460 of 1,460 codes
1011-9050-000010084068210229221APWX0132811180608(APWX01328)1011-9050-000010084068210229221APWX0048411180208(APWX00484)1011-9050-000010084068210229221APWW0214911171214(APWW02149)1011-9050-00010084068210229221APWW0215011171214(APWW02150)1011-9050-000010084068210229221APWX0026111180118(APWX00261)1011-9050-000010084068210229221APWX0026211180118(APWX00262)1011-9050-000010084068210229221APWX0140911180618(APWX01409)1011-9050-000010084068210229221APWX0141011180618(APWX01410)1011-9050-000010084068210229221APWX0141111180618(APWX01411)1011-9050-000010084068210229221APWX0141211180618(APWX01412)1011-9050-000010084068210229221APWX0141311180618(APWX01413)1011-9050-000010084068210229221APWX0141411180618(APWX01414)1011-9050-000010084068210229221APWX0141511180618(APWX01415)1011-9050-000010084068210229221APWX0141611180618(APWX01416)1011-9050-000010084068210229221APWX0141711180618(APWX01417)1011-9050-000010084068210229221APWX0141811180618(APWX01418)1011-9050-000010084068210229221APWX0141911180618(APWX01419)1011-9050-000010084068210229221APWX0142011180618(APWX01420)1011-9050-000010084068210229221APWX0142111180618(APWX01421)1011-9050-000010084068210229221APWX0142211180618(APWX01422)
- Amount recalled
- 4,207 units total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
This product could cause temporary or reversible health problems — stop using it.
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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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