FDA Device recall Z-0311-2018
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for…
- FDA Device
- Class II
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class II recall of Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for… by Philips Electronics North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0311-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
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.
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.
Identifiers
| code_info | 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2018%22
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