Known Identifiers & Locations
FEI Numbers
2517967
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0008-2014 |
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.
Reason: During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
|
2013-08-14 |
Terminated
|
View Details
|
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