The Recall Desk
HighFDA (Devices)·Z-3230-2018·Announced 2018-10-03

Philips FlexVision Monitor Ceiling Suspension Recall Due to Detachment Risk

Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and 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 physical injury from a falling object (monitor) to patients and users, but the source text does not report any actual injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Electronics North America Corporation is recalling the FlexVision Monitor Ceiling Suspension, which holds a large screen monitor. The recall affects systems with an actuator for this suspension manufactured between 2003 and May 2011. A total of 5,115 units are involved in this recall.

The recall is being issued because there is a potential for the Monitor Ceiling Suspension to detach from the actuator rotor shaft. If this occurs, the monitor may fall, creating a risk of injury to the patient, user, and bystanders. The affected products are used for vascular, cardiovascular, and neurovascular imaging applications, as well as cardiac imaging and non-vascular interventions.

The affected units were distributed nationwide in the United States and in numerous countries worldwide. Consumers and healthcare facilities should check their equipment for the specific system code and actuator details to determine if they are affected. Users should contact Philips for instructions on how to proceed with the recall.

The recalled product

Product
AIIuraXperFDlO/10, System Code 722011 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 →

Related recalls

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · falling object

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