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U.S. Department of Health and Human Services

Medical Devices

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GE Healthcare, LLC, Aestiva/5 7900 Ventilator

Recall Class: Class I

Date Recall Initiated: April 10, 2012

Products: Aestiva/5 7900 Ventilator

Serial Numbers: AMRP01031, AMRP00966, AMRP01030, AMRP00968, AMRP00967, AMRP01033, AMRP00970, AMRP00969

The Aestiva/5 7900 Ventilator was manufactured on July 2, 2010.

Use: This ventilator is intended for continuous breathing support for the care of patients who require mechanical ventilation during surgical procedures. This ventilator is used in hospitals and other health care facilities.

Recalling Firm:

GE Healthcare, LLC
9900 Innovation Drive
Wauwatosa, Wisconsin 53226

Reason for Recall:

GE Healthcare has recently become aware of a potential safety issue with the Aestiva/5 7900 Ventilator. There is a potential for two vaporizers to deliver each agent at the same time. This could result in over-delivery of a single agent if both vaporizers contain the same agent, or in delivery of more than one agent. Unrecognized overdose with simultaneous inhaled anesthetics is manifested by hypotension (low blood pressure), arrhythmias (irregular breathing), and bradycardia (low heart rate) that, if persists and remains unrecognized, may lead to circulatory shock. This ventilator may cause serious adverse health consequences, including death.

Public Contact:

Customers may contact the firm at 1-262-513-4122.

FDA District: Minneapolis District Office

FDA Comments:

On April 10, 2012, the firm sent an "Urgent Medical Device Correction" letter to their customers. The letter described the safety issue, safety instructions, affected product details, product corrections and contact information.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.