GE Healthcare Recalls Aespire Anesthesia Machines Due to Circuit Board Failure
GE Healthcare is recalling 46 Aespire 7900 and Aespire View anesthesia machines because a CPU circuit board defect may cause a blank display or loss of mechanical ventilation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (anesthesia machine) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 46 units of the Aespire 7900 and Aespire View anesthesia machines, model number 1009-9012-000. These devices are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The recall involves 10 units in the United States and 36 units outside the US.
The recall is due to an increased likelihood of failure of the CPU circuit board. This defect could result in a blank display or a loss of mechanical ventilation. The affected units were distributed worldwide, including in the US states of North Carolina and Oklahoma, as well as in China, India, Japan, Mexico, and Venezuela.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Patients and providers should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
- Manufacturer
- GE Healthcare
Distribution
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