The Recall Desk
HighFDA (Devices)·Z-0717-2018·Announced 2018-03-07

Philips Allura Xper FD X-ray Systems Recalled for Monitor Fall Hazard

Philips is recalling 1,486 Allura Xper FD and ORT X-ray systems because extra monitors mounted on the ceiling suspension may disengage and fall.

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 equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Philips Electronics North America Corporation is recalling 1,486 units of the Allura Xper FD and Xper FD ORT X-ray systems. These systems were distributed worldwide and nationwide in the United States. The affected units were manufactured between July 2003 and May 2017 and include specific system codes listed in the recall notice.

The recall is due to a mechanical defect where extra monitors, referred to as 7th or 8th monitors, mounted on the Monitor Ceiling Suspension (MCS) may disengage and fall. This occurs because small set screws securing the gliding rods into the support arm's aluminum block can loosen due to vibrations and forces. If a force pushes the monitor forward, it can topple over and drop to the floor if it breaks loose from its wires.

Healthcare facilities using these systems should contact Philips for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.

The recalled product

Product
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and
Affected units
1,486

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Electronics North America Corporation

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