Recall Z-0682-05 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems Sales & Service Region No. America
Tomoscan
| Date | Apr 6, 2005 (initiated Feb 10, 2005) |
| Status | Terminated |
| Reason | Potential for shift of reference lines. |
| Root cause | Other |
| Action | On 2/10/05 the firm''s field engineers began visiting customer sites providing them with an addendum to the Instructions for Use Manual. |
| Quantity | 138 |
| Distribution | Devcices were distributed to hospitals and medical centers throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.