VersaRad Generator
FDA device recall Z-0787-05 · posted 2005-05-03 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- Some VersaRad Systems have a faulty weld that may result in oil leakage.
- Action taken
- Customers were sent notification letters.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYB
- Quantity affected
- 38 units
- Distribution
- Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
- Date initiated
- 2004-09-30
- Date posted
- 2005-05-03
- Date terminated
- 2012-03-13
- Location
- Denver, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX (K880530) | Fischer Imaging Corp. | 1988-03-03 |