Recall – X-Ray system table can lock-up

Company: Philips North America Llc
Date of Enforcement Report: 11/17/2021
Class II

PRODUCT

Philips Azurion Interventional Fluoroscopic X-Ray System

  • Software version: 2.1.x
  • Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

Recall Number: Z-0213-2022

REASON

When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

RECALLING FIRM/MANUFACTURER

Philips North America Llc on 9/24/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

428 (US); 581 (OUS)

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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