Fabius GS Anesthesia Machine. Catalog number 8604699
FDA device recall Z-0048-2007 · posted 2006-10-19 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- One of four casters may break loose from chassis
- Action taken
- The recalling firm issued recall letters to their customers 10/03/2006 to inform them of the problem and that a service represenative will contact them to schedule an inspection of their machines. Should the inspections revealed any affected machines, the machines will be repaired free of charge.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 429 units
- Distribution
- Nationwide and Canada.
- Date initiated
- 2006-10-03
- Date posted
- 2006-10-19
- Date terminated
- 2007-08-07
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419) | Draeger Medical, Inc. | 2004-10-08 |