The Recall Desk
HighFDA (Devices)·Z-3216-2018·Announced 2018-10-03

Philips INTEGRIS Allura Monitor Ceiling Suspension Recall for Detachment Risk

Philips is recalling INTEGRIS Allura 15-12 systems because the monitor ceiling 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, fitting the High severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling the INTEGRIS Allura 15-12 (mono) system, System Code 722043, used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall involves 5,115 total units distributed worldwide, including nationwide distribution in the United States and various international countries.

The recall is due to a potential defect where the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft. If this occurs, the monitor may fall to the ground, creating 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.

Healthcare facilities and users should contact Philips Electronics North America Corporation for instructions on how to address this safety issue. The source text does not specify a particular action for consumers to take beyond the general recall notification.

The recalled product

Product
INTEGRIS Allura 15-12 (mono), System Code 722043 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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