Recall Z-0099-04 ยท EHD Unit, X-Ray, Extraoral With Timer
Philips Medical Systems Sales & Service Region No. America
Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
| Date | Jul 20, 2004 (initiated Oct 10, 2003) |
| Status | Terminated |
| Reason | The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories. |
| Root cause | Other |
| Action | The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier. |
| Quantity | 536 units |
| Distribution | The firm distributes to hospitals and medical centers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971365 | PHILIPS INTEGRIS H5000 Philips Medical Systems North America, Inc., May 14, 1997 |