Philips FlexVision Monitor Ceiling Suspension Recall for Detachment Risk
Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and 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 the FlexVision Monitor Ceiling Suspension, which is used to hold large screen monitors in medical imaging environments. The recall affects systems with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011. A total of 5,115 units are involved in this recall.
The recall is being issued because there is a potential for the Monitor Ceiling Suspension to detach from the actuator rotor shaft. If this occurs, the monitor may fall, creating a risk of injury to the patient, user, or bystanders. The affected products were distributed worldwide, including in the United States and numerous international countries.
Healthcare facilities and users should stop using the affected FlexVision Monitor Ceiling Suspensions and contact Philips for further instructions on the recall and remediation.
The recalled product
- Product
- AIIuraXperFDlO, System Code 722010 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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