Azurion recallZ-2285-2026 · Philips Medical Systems Nederland B.V. · initiated Dec 7, 2023

Why it was recalled

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

FDA root cause category: Software design

What the company is doing

Philips issued an IMPORTANT PRODUCT NOTICE to its consignees on 12/7/2023 via USPS mail. The notice explained the problem with the device and the circumstances under which if could occur and actions to be taken to minimize the effect of the problem. The notice further instructed the user to: - Keep this Important Product Notice with the documentation of the system until Philips corrects your system. - Circulate this notice to all users of the system so that they are aware of the issue. - Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Important Product Notice. For further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

Recall details

Recall number

Z-2285-2026

Status

Open, Classified

Initiated by the company

Dec 7, 2023

Posted by the FDA

Jun 1, 2026

Recalling firm

Philips Medical Systems Nederland B.V.

Quantity

27 units

Product code

OWB

FDA submissions

K172822, K181830, K200917

Distribution

US Nationwide distribution.

Product description

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths205 reports
• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls104 reports

Product lines

• AzurionPhilips Medical Systems Nederland B.V. · 22 models · 9,199 reports · 71 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98977).

• Z-2284-2026 · Open, Classified
  Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2286-2026 · Open, Classified
  Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2287-2026 · Open, Classified
  Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2288-2026 · Open, Classified
  Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2289-2026 · Open, Classified
  Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2290-2026 · Open, Classified
  Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
• Z-2291-2026 · Open, Classified
  Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key