Tec 850 SEV Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery
GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices 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: This is an FDA Class II medical device recall with a manufacturing defect affecting anesthetic delivery. Although no illnesses or injuries have been reported, the defect creates a risk-of-harm situation where vaporizers may deliver insufficient anesthesia during surgery. Per the rubric, a risk-of-harm product without reported injury scores as High (3).
Plain-English summary
GE Medical Systems, LLC is recalling the Tec 850 SEV Anesthesia Vaporizer (Reference Number 1177-9850-SEV) due to a manufacturing issue.
The vaporizers can deliver less anesthetic agent than the dial setting indicates. Approximately 8,319 units have been distributed in the United States and globally.
Details regarding serial numbers and further information are available from the FDA.
The recalled product
- Product
- Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- anesthetic-underdosing
- dosage-inaccuracy
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: 00840682124737
Distribution
Distributed nationwide across the United States.
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