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Medium risk Medical DevicesClass II

Philips Azurion 3M15 Recall

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 Sof

Updated December 7, 2023

Philips Azurion 3M15 imaging systems may display a dark, unusable image during Roadmap Pro procedures if the footswitch pedal is lightly tapped before a scan. This could delay or compromise clinical imaging.

Is the PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled? Yes. This product was recalled by FDA on December 7, 2023. Details below.

What is recalled

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

Am I affected

You're affected if your facility uses a Philips Azurion 3M15 with Model Number 722064 or 722222 running Roadmap Pro with software version R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. Check your device label and software settings menu.

What to do right now

Contact Philips Medical Systems to inquire about a software update or corrective action for your device. Document any instances of dark images during Roadmap Pro procedures.

The hazard

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.

Brands affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2285-2026
Classification
Class II
Recalled
December 7, 2023
Read the official notice

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