Reported Jan 27, 2016 · Terminated
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire…
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, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
- Lot codes and dates
- AESPIREAESPIRE VIEW
413 of 413 codes
7900ANCU00662ANCU00813ANCU00814ANCU00815ANCU00816ANCU00817ANCU00818ANCU00597ANCU00598ANCU00599ANCU00600ANCU00601ANCU00671ANCU00672ANCU00673ANCU00676ANCU00678ANCU00683ANCU00830ANCU00832ANCU00870ANCU00871ANCU00872ANCU00873ANCU00874ANCU00875ANCU00629ANCU00630ANCU00638ANCU00639ANCU00640ANCU00641ANCU00806ANCU00604ANCU00684ANCU00836ANCU00837ANCU00839ANCU00786ANCU00680ANCU00681ANCU00625ANCU00626ANCU00677ANCU00618ANCU00619ANCU00620ANCU00602ANCU00603ANCU00448ANCU00449ANCU00770ANCU00771ANCU00865ANCU00866ANCU00867ANCU00803ANCU00605ANCU00663
669 of 669 codes
APHU01097APHU00884APHU00885APHU00886APHU00887APHU00888APHU01044APHU01045APHU01046APHU01047APHU01048APHU01049APHU01109APHU00641APHU00560APHU01035APHU00923APHU00924APHU00969APHU00970APHU00971APHU00895APHU00972APHU00742APHU01133APHU01134APHU00737APHU00738APHU00739APHU00740APHU01180APHU00554APHU00555APHU00500APHU00731APHU00732APHU00733APHU00734APHU00735APHU00736APHU00777APHU01087APHU01126APHU01127APHU01128APHU00493APHU00881APHU00882APHU00995APHU00553APHU00559APHU00528APHU01031APHU00516APHU00580APHU00581APHU00582APHU00583APHU00610APHU01132
- AESPIRE
- Amount recalled
- 1081
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.
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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