The Recall Desk
HighFDA (Devices)·Z-3225-2018·Announced 2018-10-03

Philips Allura Xper FD1O C Ceiling Monitor Recall for Detachment Risk

Philips is recalling 5,115 Allura Xper FD1O C systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

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 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 5,115 Allura Xper FD1O C systems (System Code 722001) used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall is due to a potential defect in the Monitor Ceiling Suspension, which holds a large screen monitor.

The Monitor Ceiling Suspension may detach from the actuator rotor shaft, causing the monitor to fall. If the monitor falls, there is a risk of injury to the patient, user, or bystander. The affected systems are those with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should contact Philips for further instructions on how to address this safety issue.

The recalled product

Product
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Imaging Equipment
Hazard
Affected units
5,115

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 27 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 27 products in this recall →

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Same manufacturer · Philips Electronics North America Corporation

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