Reported Aug 14, 2024 · Ongoing
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Philips Medical Systems Nederland B.v.
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 NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- Philips Azurion Interventional Fluoroscopic X-ray
- System with Software Version NumberR1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the
- following clinical application areasvascular, non-vascular, cardiovascular, and neuro procedure
- Model Numbers
722063722064722067722068722078 and 722079
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00884838085275(1) 722063 (01)00884838085275(21) 2 00884838085282(2) 722064 (01)00884838085282(21) 3 00884838085350(3) 722067 (01)00884838085350(21) 4 00884838085367(4) 722068 (01)00884838085367(21) 5 00884838085251(5) 722078 (01)00884838085251(21) 6 00884838085268(6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2 - Amount recalled
- 3011 units
Where it was sold
- Nationwide
Why it was recalled
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
This product could cause temporary or reversible health problems — stop using it.
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