medical Class II Updated 2018-10-03

Philips Electronics North America Corporation recalls Allura Xper F020 DR Table, System Code 722023 Vascular,

Recalled Product

Allura Xper F020 DR Table, System Code 722023 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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