FDAJune 11, 2018device

Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,athere...

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

The hazard

The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.

What to do

FDA enforcement status: Terminated

Brands named

philips healthcarephilips

Recall history

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

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