High FDA (Devices)·Z-3228-2018·Announced 2018-10-03

Philips AlluraXperFOlO/lO Ceiling Monitor Suspension Recall

Philips is recalling 5,115 AlluraXperFOlO/lO systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

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 the monitor may fall and cause injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk.

Plain-English summary

Philips Electronics North America Corporation is recalling 5,115 AlluraXperFOlO/lO systems, System Code 722005, used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall affects systems manufactured between 2003 and May 2011 that include an actuator for the FlexVision Monitor Ceiling Suspension.

The recall is due to a potential defect where the Monitor Ceiling Suspension may detach from the actuator rotor shaft. If this occurs, the large screen monitor may fall from the ceiling, creating a risk of injury to patients, users, and bystanders.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should contact Philips for instructions on how to address the defect.

The recalled product

Product: AlluraXperFOlO/lO, System Code 722005 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: falling-object
impact-injury
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 →

Same manufacturer · Philips Electronics North America Corporation

See all →

High
Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
Moderate
Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
High
Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
High
Philips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
High
Philips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03

Same hazard · falling object