Radiomat Lightweight Cassettes
FDA device recall Z-1404-05 · posted 2005-08-25 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
- Action taken
- Consignees were notified by letter on/about 07/29/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- IXA
- Quantity affected
- 9055 units
- Distribution
- Nationwide, Canada
- Date initiated
- 2005-01-26
- Date posted
- 2005-08-25
- Date terminated
- 2006-06-20
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE (K023020) | Agfa Corp. | 2002-09-26 |