Recall Z-1997-2019— Philips Medical Systems Nederlands
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-11-30, terminated 2024-03-27. It names one FDA 510(k) clearance: K172822. Product: Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2. Reason: 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..
- Recalling firm
- Philips Medical Systems Nederlands
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-30
- Terminated
- 2024-03-27
- Firm location
- Best, N/A, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.