Draeger Fabius Anesthesia Machines Recalled for Electrical Clearance Defects
Draeger Medical is recalling 1,127 Fabius anesthesia machines worldwide because some units failed high-voltage tests and did not maintain minimum electrical clearance.
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: The recall involves a risk-of-harm product (electrical clearance failure in a medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Draeger Medical, Inc. is recalling 1,127 units of the Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, and Fabius Tiro D-M anesthesia machines. These devices are used to administer anesthesia and ventilation to patients during surgical procedures. The recall covers units distributed in the United States and numerous countries worldwide, including Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall was initiated because during final testing, some units did not pass the high-voltage test. Additionally, the minimum clearance between an electrical component and the unit housing was not maintained for some units from a specific batch. This defect poses a potential electrical safety risk.
Healthcare facilities and users should identify affected units by checking the part numbers (8607000, 8606000, 8608400) and specific lot numbers listed in the official recall notice. Users should contact Draeger Medical, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 1,127
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 (20)
- ASED-0006
- ASED-0074
- ASED-0291
- ASEC-0056
- ASEC-0205
- ASED-0007
- SED-0075 ASED-0292
- ASEC-0061
- ASEC-0206
- ASED-0020
- ASED-0079
- ASED-0293
- ASEC-0062
- ASEC-0207
- ASED-0021
- ASED-0139
- ASED-0294
- ASEC-0070
- ASEC-0208
- ASED-0023
Distribution
Distributed nationwide across the United States.
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