ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, compone
FDA device recall Z-0352-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
- Action taken
- Consignees were notified by letter on/about December 1, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 1059 units
- Distribution
- Nationwide
- Date initiated
- 2005-11-18
- Date posted
- 2006-01-06
- Date terminated
- 2012-01-12
- 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 |
|---|---|---|
| ADC COMPACT (AGFA DIAGNOSTIC CENTER) (K974597) | Bayer Corp., Agfa Div. | 1998-03-09 |