Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER,
FDA device recall Z-2338-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 111 units
- Distribution
- Nationwide
- Date initiated
- 2008-07-07
- Date posted
- 2008-09-23
- Date terminated
- 2010-03-08
- Location
- Telford, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419) | Draeger Medical, Inc. | 2004-10-08 |