The Recall Desk
HighFDA (Devices)·Z-3219-2018·Announced 2018-10-03

Philips INTEGRIS Allura 9 F FDXD Monitor Suspension Recall

Philips is recalling INTEGRIS Allura 9 F FDXD 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 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 without reported harm.

Plain-English summary

Philips Electronics North America Corporation is recalling 5,115 INTEGRIS Allura 9 F FDXD systems, System Code 722497. These systems are used for vascular, cardiovascular, and neurovascular imaging, cardiac diagnostics, and non-vascular interventions. The recall affects all systems with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.

The recall is due to a potential safety hazard 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, posing a risk of injury to patients, users, and bystanders.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. No specific lot numbers or additional dates are provided in the source text beyond the manufacturing period for the actuator.

The recalled product

Product
INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
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

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