GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery
Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.
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 FDA Class II medical device recall involves no reported hospitalizations or illnesses to date. The manufacturing defect poses a risk of inaccurate anesthetic dosage during surgical procedures. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling certain Tec 6 Plus and Tec 800 series anesthesia vaporizers due to a manufacturing issue that can result in delivery of less anesthetic agent than the vaporizer dial setting indicates.
The affected vaporizers may under-deliver anesthetic agent to patients during surgical procedures. This dosing discrepancy occurs due to the manufacturing defect and could affect the accuracy of anesthesia administration.
Approximately 1,594 units have been distributed in the United States and globally. Healthcare facilities should immediately identify affected devices using the provided serial numbers and cease their use pending further guidance from GE Medical Systems.
Users who have questions about their devices should contact GE Medical Systems with their device serial number. Do not rely on the dial setting to ensure accurate dosing without verification from the manufacturer.
The recalled product
- Product
- Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- anesthetic-under-delivery
- dosing-error
- manufacturing-defect
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: 00840682124751
Distribution
Distributed nationwide across the United States.
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