Philips Medical Systems Nederlands: Medical Device Recall in 2019 - (Recall #: Z-1997-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

Product Classification:

Class II

Date Initiated: November 30, 2018

Date Posted: August 7, 2019

Recall Number: Z-1997-2019

Event ID: 83366

Reason for Recall:

Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

Status: Terminated

Product Quantity: 229

Code Information:

software version R1.2

Distribution Pattern:

Nationwide

Voluntary or Mandated:

FDA Mandated