Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Detachment Risk
Philips is recalling 5,115 Allura Xper FD2O 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 High severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 5,115 Allura Xper FD2O Biplane systems (System Code 722008) used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall is due to a potential defect in the Monitor Ceiling Suspension, which holds a large screen monitor.
The Monitor Ceiling Suspension may detach from the actuator rotor shaft, causing the monitor to fall. If the monitor falls, there is a risk of injury to the patient, user, and bystanders. The affected systems are those with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.
The recall covers systems distributed worldwide, including all 50 U.S. states, the District of Columbia, and numerous international countries. Consumers and healthcare facilities should contact Philips for instructions on how to address this issue.
The recalled product
- Product
- Allura Xper FD2O Biplane, System Code 722008 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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- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
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