High FDA (Devices)·Z-3222-2018·Announced 2018-10-03

Philips Allura Xper FD2O Monitor Ceiling Suspension Recall

Philips is recalling Allura Xper FD2O 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 Allura Xper FD2O systems (System Code 722012) used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall involves systems manufactured between 2003 and May 2011 that include an actuator for the FlexVision Monitor Ceiling Suspension.

The recall is issued because the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft. If this occurs, the monitor may fall, creating a risk of injury to patients, users, and bystanders.

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

The recalled product

Product: Allura Xper FD2O, System Code 722012 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
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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