Azurion lnterventional Fluoroscopic X-ray System recall: Software Issue
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Why was Azurion lnterventional Fluoroscopic X-ray System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
software version R1.2
- Product
- Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- Recalling firm
- Philips Medical Systems Nederlands
- Quantity
- 229
- Distribution
- Nationwide
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)