The Recall Desk
HighFDA (Devices)·Z-3231-2018·Announced 2018-10-03

Philips AIIura Xper F010 DR Table Recall for Monitor Detachment Risk

Philips is recalling AIIura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury to patients and staff.

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 (falling monitor) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of harm.

Plain-English summary

Philips Electronics North America Corporation is recalling 5,115 AIIura Xper F010 DR Tables, System Code 722022. These systems are used for vascular, cardiovascular, neurovascular, and cardiac imaging applications, as well as non-vascular interventions. The recall affects all systems equipped with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.

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 could fall from the ceiling. The source text notes that a falling monitor presents a risk of injury to the patient, the user, and bystanders.

The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Canada, the United Kingdom, and various nations in Europe, Asia, and the Americas. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product
AIIura Xper F010 DR Table, System Code 722022 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

See all →

Same hazard · falling object

See all →