—#108604

Product

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

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K023366
Affected lot / code info: Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2012-04-10
Posted by FDA: 2012-06-17
Terminated: 2012-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.