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Philips Healthcare recalls Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, in
Recalled August 1, 2018 · FDA recall Z-2498-2018 · Philips Healthcare
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. · FDA Class II
Units
459 affected systems
Sold at
US Nationwide Distribution
Description
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.
Product
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,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
Manufacturer(s)
Philips Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →