Recall Z-2338-2008 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
| Date | Sep 23, 2008 (initiated Jul 7, 2008) |
| Status | Terminated |
| Reason | The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable. |
| Root cause | Process control |
| Action | The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance. |
| Quantity | 111 units |
| Distribution | Nationwide |
| 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 |