Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR
FDA device recall Z-1059-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Pinhole collimator defective.
- Action taken
- Firm will be inspecting and replacing defective collimators, in addition, an advisory letter will be sent to all sites to alert to the inspection and replacement. Recall began May 31, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 40
- Distribution
- Nationwide.
- Date initiated
- 2004-05-31
- Date posted
- 2004-07-20
- Date terminated
- 2005-07-13
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GCA-7200A (K931297) | Toshiba America Medical Systems, In.C | 1993-07-27 |