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Medium risk Drugs & MedicationsClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 MEDICAL SYSTEMS NEDERLAND B.V. is recalling 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. 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.

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, 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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Stop using this product and contact the seller or manufacturer.

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
Drugs & Medications
Recall ID
fda-Z-2285-2026
Classification
Class II
Recalled
December 7, 2023
Read the official notice

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