Recall Z-0022-06 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems North America Co. Phillips
Interis Allura BiPlane X-Ray System
| Date | Aug 31, 2005 (initiated Jul 27, 2005) |
| Status | Terminated |
| Reason | 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick. |
| Root cause | Other |
| Action | A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed. |
| Quantity | 43 units |
| Distribution | Devices were distributed to hospitals/medical centers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., Sep 6, 2000 |