Philips Medical Systems Sales & Service Region No. America
OmniDiagnost System
| Date | Jul 20, 2004 (initiated Jul 17, 2003) |
| Status | Terminated |
| Reason | Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID). |
| Root cause | Other |
| Action | On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons. |
| Quantity | 52 |
| Distribution | The firm distributed devices to 81 hospitals and medical centers located throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982993 | PHILIPS OMNIDIAGNOST Philips Medical Systems, Inc., Sep 29, 1998 |