Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Reported: August 7, 2019 Initiated: November 30, 2018 #Z-1997-2019
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.
Details
- Recalling Firm
- Philips Medical Systems Nederlands
- Units Affected
- 229
- Distribution
- Nationwide
- Location
- Best, N/A
Frequently Asked Questions
What product was recalled? ▼
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2. Recalled by Philips Medical Systems Nederlands. Units affected: 229.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-1997-2019.
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