The Recall Desk
HighFDA (Devices)·Z-3217-2018·Announced 2018-10-03

Philips INTEGRIS Allura 15-12 Biplane Monitor Suspension Recall

Philips is recalling INTEGRIS Allura 15-12 biplane 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 criteria for a High severity score.

Plain-English summary

Philips Electronics North America Corporation is recalling 5,115 INTEGRIS Allura 15-12 (biplane) systems, System Code 722044. These systems are used for vascular, cardiovascular, neurovascular, and cardiac imaging applications, as well as non-vascular interventions.

The recall is due to a potential defect in the Monitor Ceiling Suspension, which holds a large screen monitor. The suspension may detach from the actuator rotor shaft, causing the monitor to fall. If this occurs, 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. These systems were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers and healthcare facilities should contact Philips for instructions on how to address this issue.

The recalled product

Product
INTEGRIS Allura 15-12 (biplane), System Code 722044 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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