PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2026-06-10 Health serious FDA
Health · FDA · Recall #FDA-Z-2285-2026
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0,… Recall
Issued June 10, 2026 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In June 2026, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0,…, a serious health recall reported by the FDA. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your remedy. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy ():
Recall details
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health
- Recall date
- June 10, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2285-2026
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 17 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.