VersaRad/Traumex General Radiographic System.
FDA device recall Z-0974-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.
- Action taken
- Consignees were notified by letter on 4/23/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYB
- Quantity affected
- 138 units
- Distribution
- Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
- Date initiated
- 2004-04-23
- Date posted
- 2004-07-20
- 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 |