FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederlands: Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- Recall number
- Z-1997-2019
- Recalling firm
- Philips Medical Systems Nederlands
- Product
- Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- Status
- Terminated
- Initiated
- 2018-11-30
- Posted
- not on file
- Terminated
- 2024-03-27
- 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.
- Root cause
- Device Design
- Action
- On November 30, 2018, Philips initiated a software update in the field. Among other performance improvements , this software update included the correction for poor image quality under very specific situations.
- Quantity
- 229
- Distribution
- Nationwide
- Lot, serial or model codes
- software version R1.2
- 510(k) numbers
- ["K172822"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28