Reported Jan 27, 2016 · Terminated
GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda…
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 CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The 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
- AVANCE
1,327 of 1,327 codes
APWU00723APWU00724APWU01057APWU01058APWU01059APWU01785APWU01827APWU01988APWU01989APWU01990APWU01991APWU01992APWU01993APWU01994APWU01995APWU01996APWU01997APWU01576APWU01577APWU01578APWU00707APWU00708APWU00709APWU00710APWU00711APWU00712APWU00713APWU01486APWU01487APWU01488APWU01489APWU01490APWU01491APWU01492APWU01493APWU01494APWU01495APWU01825APWU01909APWU02017APWU02018APWU02019APWU02020APWU01054APWU01055APWU01056APWU00840APWU00841APWU00842APWU00843APWU00844APWU00845APWU00846APWU00847APWU01608APWU01609APWU01610APWU01611APWU01612APWU01613
AVANCEANBU00119ANBU00124ANBU00134ANBU00138ANBU00139ANBU00163ANBU00121ANBU00122ANBU00123ANBU00125ANBU00126ANBU00127ANBU00128ANBU00129ANBU00130ANBU00131ANBU00120
1,284 of 1,284 codes
CS2APKU01696APKU01697APKU01698APKU01699APKU01872APKU01237APKU01238APKU01239APKU01240APKU01241APKU01242APKU01243APKU01569APKU01570APKU02074APKU01701APKU01427APKU01694APKU01053APKU02163APKU02164APKU01200APKU01201APKU01202APKU01203APKU01204APKU01686APKU01687APKU01688APKU01904APKU01810APKU01447APKU01742APKU01743APKU01656APKU01657APKU01658APKU01682APKU01683APKU01684APKU01685APKU01729APKU01730APKU01731APKU01454APKU01455APKU01456APKU01457APKU01458APKU01459APKU01460APKU01461APKU01462APKU01463APKU01464APKU01465APKU01466APKU01467APKU01468
- Amount recalled
- 2627
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
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
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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