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Philips Medical Systems Nederlands recalls Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Recalled August 7, 2019 · FDA recall Z-1997-2019 · Philips Medical Systems Nederlands
Hazard
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. · FDA Class II
Units
229
Sold at
Nationwide
Description
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.
Product
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Manufacturer(s)
Philips Medical Systems Nederlands
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →