Reported Aug 7, 2019 · Terminated
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Philips Medical Systems Nederlands
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederlands · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- Lot codes and dates
- software version R1.2
- Amount recalled
- 229
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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