Philips Healthcare: 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.

Agency Publication Date: July 25, 2018

Affected Products

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.

Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27

Product: UNIQ 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.

UNIQ 1.0.10 UNIQ 1.0.10.5

Product: 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.

Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80402

Status: Resolved

Manufacturer: Philips Healthcare

Manufactured In: United States

Units Affected: 3 products (459 affected systems)

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Sources: FDA iRES · Raw API Response

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Affected Products

Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27

UNIQ 1.0.10 UNIQ 1.0.10.5

Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5