Recall Z-0311-2018 ยท KPR System, X-Ray, Stationary
Philips Electronics North America Corporation
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
| Date | Jul 14, 2017 |
| Status | Terminated |
| Reason | If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position. |
| Root cause | Under Investigation by firm |
| Action | If the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is . applied. This may happen when the detector is rotated clockwise from landscape to portrait position. The Wireless Portable Detector (WPD) is fixed in the Mobile Detector Holder via a lock mechanisrn. The 4 countersunk screws, that are used to attach the lock mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down whe |
| Quantity | 412 |
| Distribution | 412 units affected. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |