medical Class II Updated 2018-10-03

Philips Electronics North America Corporation recalls Allura Xper F010/10 DRTable, System Code 722019 Vascular

Recalled Product

Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions


Hazard / Issue

There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected
View official government recall

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