Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery
GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.
What this means for you
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: FDA Class II medical device that poses a risk of harm (inadequate anesthesia delivery) but no illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury qualifies as High severity (Score 3).
Plain-English summary
The Tec 820 SEV Anesthesia Vaporizer is being recalled due to a manufacturing issue that can cause the device to deliver less anesthetic agent than the vaporizer dial setting indicates.
Approximately 928 Tec 820 SEV units are affected by this recall. These vaporizers have been distributed nationwide in the United States and globally. A complete list of affected serial numbers is available from the FDA recall notice.
Healthcare facilities and anesthesia providers using affected units should verify the serial numbers of their devices against the recall list and contact GE Medical Systems for instructions regarding replacement or other remedial actions.
The recalled product
- Product
- Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- under-dosing
- anesthesia-delivery-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00840682124720
Distribution
Distributed nationwide across the United States.
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