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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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