Home / Recalls / Philips Medical Systems Nederlands / Z-1997-2019

Z-1997-2019 Class II Terminated

Recalled by Philips Medical Systems Nederlands — Best, N/A

Recall Details

Product Type
Devices
Report Date
August 7, 2019
Initiation Date
November 30, 2018
Termination Date
March 27, 2024
Voluntary/Mandated
FDA Mandated
Product Quantity
229

Product Description

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

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.

Distribution Pattern

Nationwide

Code Information

software version R1.2

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  • Z-0929-2019 Class II — NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Ima (December 21, 2018)
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  • Z-0897-2019 Class II — Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System (December 21, 2018)
  • Z-0910-2019 Class II — Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System (December 21, 2018)