Z-1997-2019 Class II Terminated
FDA device recall Z-1997-2019 was initiated by Philips Medical Systems Nederlands on Nov 30, 2018 and is designated Class II. 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… The recall status is terminated (terminated Mar 27, 2024). Affected quantity: 229.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2019
- Initiation Date
- Nov 30, 2018
- Termination Date
- Mar 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1997-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026