Recall Z-0526-03 ยท IZL System, X-Ray, Mobile
Philips Medical Systems
Philips BV300 Mobile X-Ray System
| Date | Feb 1, 2003 (initiated Sep 27, 2002) |
| Status | Terminated |
| Reason | The C-bow support can bend and break allowing C-arm to fall from support |
| Root cause | Other |
| Action | The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct. |
| Quantity | 229 devices |
| Distribution | The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953910 | PHILIPS BV 300 SERIES Philips Medical Systems North America, Inc., Oct 18, 1995 |