The Recall Desk
SevereFDA (Devices)·Z-1787-2012·Announced 2012-06-27

GE Healthcare Recalls Aestiva 7900 Anesthesia Machines Due to Missing Interlock

GE Healthcare is recalling eight Aestiva 7900 anesthesia machines because a missing interlock slide may allow two vaporizers to deliver agents simultaneously.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the defect involves a structural failure in a critical medical device that could lead to significant patient harm through incorrect drug delivery.

Plain-English summary

GE Healthcare, LLC is recalling eight units of the Aestiva/5 7900 SmartVent anesthesia machine used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. The recall is due to a potential safety issue where the interlock slide mechanism is missing from the 3-vaporizer manifold.

The missing mechanism creates a potential for two vaporizers to deliver anesthetic agent at the same time. This could result in the over-delivery of a single agent if both vaporizers contain the same substance, or the delivery of more than one agent simultaneously.

The affected units were distributed nationwide, including in Alabama, Florida, Georgia, Missouri, and Virginia. The specific serial numbers for the recalled units are AMRP01031, AMRP00966, AMRP01030, AMRP00968, AMRP00967, AMRP01033, AMRP00970, and AMRP00969. Healthcare facilities should verify their equipment against these serial numbers and contact GE Healthcare for further instructions.

The recalled product

Product
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Manufacturer
GE Healthcare, LLC
Affected units
8

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically: