Recall Z-1059-04 ยท KPS System, Tomography, Computed, Emission
Toshiba American Med Sys Inc
Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
| Date | Jul 20, 2004 (initiated May 31, 2004) |
| Status | Terminated |
| Reason | Pinhole collimator defective. |
| Root cause | Other |
| Action | 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. |
| Quantity | 40 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931297 | GCA-7200A Toshiba America Medical Systems, In.C, Jul 27, 1993 |