Philips Electronics North America Corporation recalls Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector f…

Recall date

July 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0311-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

412 units affected.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.