FDA recall Z-0311-2018

Philips Electronics North America Corporation · Class II · device

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 for recall

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.

Distribution

412 units affected.

Key facts

Status
Terminated
Initiation date
2017-07-14
Report date
2018-01-10
Termination date
2020-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2018