Z-1787-2012Class I

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

Name: Z-1787-2012 GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems
Creator: GE Healthcare, LLC
Published: 2012-04-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-04-10 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems on 2012-04-10. FDA classified it as Class I and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1787-2012
Classification: Class I
Status: Terminated
Initiated: 2012-04-10
Posted: 2012-06-17
Terminated: 2012-07-09
Recalling firm: GE Healthcare
Product: GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Product code: CBK Ventilator, Continuous, Facility Use
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.
Quantity in commerce: 8
Distribution: Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.
Product codes and lots: Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1787-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1787-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-17

Product code CBK

K023366Class IIDatex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. / cleared 2003-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)