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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 5,115
Distribution
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
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