Philips Healthcare recalls Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventio…

Recall date

June 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2500-2018

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Centron 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.