FDAJuly 16, 2018device

INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips electronics north americaphilipsphilips electronics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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