Philips Healthcare: Medical Device Recall in 2018 - (Recall #: Z-2498-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 11, 2018

Date Posted: August 1, 2018

Recall Number: Z-2498-2018

Event ID: 80402

Reason for Recall:

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.

Status: Terminated

Product Quantity: 459 affected systems

Code Information:

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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated