FDA Medical Device Recalls (openFDA)
Philips North America: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- Recall number
- Z-0597-2026
- Recalling firm
- Philips North America
- Product
- Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- Status
- Open, Classified
- Initiated
- 2025-10-27
- Posted
- 2025-12-09
- Terminated
- not on file
- Reason
- Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.
- Quantity
- 110
- Distribution
- U.S.
- Lot, serial or model codes
- Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016
- 510(k) numbers
- K200917
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3006648320
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
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