CLASS I Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

Aestiva/5 7900 SmartVent, anesthesia machine recalled by GE Healthcare

GE Healthcare is recalling Aestiva/5 7900 SmartVent, anesthesia machine, distributed nationwide in the US. The recall was initiated on 10 Apr 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

Quantity recalled8

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1787-2012
FDA event ID: 61639
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class I
Status: Terminated
Recall initiated: 10 Apr 2012
FDA classified: 17 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Apr 2012	Recall initiated by company
17 Jun 2012	Classified by FDA	+68 days
27 Jun 2012	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m

Product as listed by the FDA

GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

Where it was distributed

Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.

Nationwide Alabama Florida Georgia Missouri Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

Where was it sold?

Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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