The Recall Desk
HighFDA (Devices)·Z-0311-2018·Announced 2018-01-10

Philips Mobile Detector Holder Recalled Due to Potential Detector Drop Hazard

Philips is recalling 412 Mobile Detector Holders for Stationary X-ray Systems because the lock mechanism may fail, causing the detector to drop.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling heavy equipment) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.

Plain-English summary

Philips Electronics North America Corporation is recalling 412 units of the Mobile Detector Holder for Stationary X-ray Systems (RF System). These devices are used to position wireless portable detectors in the room for X-ray exposures and support the detector with or without a grid. The affected units were manufactured and distributed between March 2015 and March 2017.

The recall is due to a defect in the lock mechanism of the movable clamp. If the mechanism is not adjusted properly or secured, the portable detector can drop when the movable clamp is at the bottom and additional force is applied. This hazard may occur when the detector is rotated clockwise from a landscape to a portrait position.

Healthcare facilities and users of these devices should stop using the affected Mobile Detector Holders immediately. Philips is the recalling firm and is responsible for managing the recall. Users should contact Philips for instructions on how to resolve the issue or obtain a replacement.

The recalled product

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.
Affected units
412

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Philips Electronics North America Corporation

See all →