Recall Z-0008-2014 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
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.
| Date | Oct 10, 2013 (initiated Aug 14, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm, Drager, sent an "Urgent Medical Device Recall" letter dated August 2013 to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that in the event of a failure, manual ventilation mode should be used and that Draeger reps would be contacting customers to schedule the replacement of the power supply. The customers were instructed to notify personnel accordingly. If you have any questions, contact Director, Quality at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or se |
| Quantity | 1127 units |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc., Oct 8, 2004 |