GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect
GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and 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 the hazard involves a risk of harm (inadequate ventilation/airway clearance) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Medical Systems, LLC is recalling 952 units of the Aisys and Aisys CS2 anesthesia machines. These devices are intended to provide general inhalation anesthesia and ventilator support to neonatal, pediatric, and adult patients.
The recall is due to a defect where the vacuum suction tubing could be kinked within the machine. This kinking may result in suction performance below the 20 lpm required by ISO 10079-3. Inadequate suction performance could prevent the machine from clearing the patient's airway and provide inadequate ventilation.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should check their inventory against the specific serial numbers and UDI identifiers listed in the official recall notice to determine if their equipment is affected.
The recalled product
- Product
- GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
- Manufacturer
- GE Medical Systems, LLC
Distribution
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