Reported Nov 21, 2018 · Terminated

Aisys 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 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

Lot codes and dates: Model Number, UDI Number, (Serial
Number)
702 of 702 codes
2097674-001-US
Not Applicable
(5470345-30)
2097674-001-US
Not Applicable
(5470345-31)
2097674-001-US
Not Applicable
(5470345-32)
1011-9000-000
Not Applicable
(ANAK00774)
1011-9000-000
Not Applicable
(ANAK00775)
1011-9000-000
Not Applicable
(ANAL01201)
1011-9000-000
Not Applicable
(ANAL01234)
1011-9000-000
Not Applicable
(ANAL01235)
1011-9000-000
Not Applicable
(ANAL01236)
1011-9000-000
Not Applicable
(ANAL01237)
1011-9000-000
Not Applicable
(ANAL01238)
1011-9000-000
Not Applicable
(ANAL01240)
1011-9000-000
Not Applicable
(ANAL01494)
1011-9000-000
Not Applicable
(ANAL01495)
1011-9000-000
Not Applicable
(ANAL01551)
1011-9000-000
Not Applicable
(ANAM01023)
1011-9000-000
Not Applicable
(ANAM01024)
1011-9000-000
Not Applicable
(ANAM01025)
1011-9000-000
Not Applicable
(ANAM01026)
1011-9000-000
Not Applicable
(ANAM01027)
Number)
252 of 252 codes
2097674-001-US
Not Applicable
(APWV01271)
2097674-001-US
Not Applicable
(APWU01812)
2097674-001-US
Not Applicable
(ANAR00714)
2097674-001-US
Not Applicable
(ANAR00741)
2097674-001-US
Not Applicable
(ANAS00330)
2097674-001-US
Not Applicable
(ANAS01319)
2097674-001-US
Not Applicable
(ANAS01320)
2097674-001-US
Not Applicable
(APWU00486)
2097674-001-US
Not Applicable
(APWU00487)
2097674-001-US
Not Applicable
(APWU00575)
2097674-001-US
Not Applicable
(APWU01267)
2097674-001-US
Not Applicable
(APWX00154)
2097674-001-US
Not Applicable
(APWX00155)
2097674-001-US
Not Applicable
(APWX00156)
2097674-001-US
Not Applicable
(APWX00157)
1011-9000-000
Not Applicable
(ANAS00456)
2097674-001-US
Not Applicable
(ANAM00764)
2097674-001-US
Not Applicable
(ANAM00765)
2097674-001-US
Not Applicable
(ANAM00766)
2097674-001-US
Not Applicable
(ANAM00767)
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.

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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By hazard

Medical device recalls

Other recalls from GE Healthcare, LLC

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX Aug 31, 2022
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700… Aug 17, 2022
Centricity PACS Software Version 7.0 SP0.0.4.7 Aug 3, 2022
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000 Jul 27, 2022
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and… Jul 13, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on… Jul 6, 2022

152 in total.

Where it was distributed

All recall categories · Browse the whole archive