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Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

FDA Device Recall #Z-1997-2019 — Class II — November 30, 2018

Recall Summary

Recall Number Z-1997-2019
Classification Class II — Moderate risk
Date Initiated November 30, 2018
Status Terminated
Voluntary FDA Mandated

Recalling Firm

Firm Philips Medical Systems Nederlands
Location Best, N/A
Product Type Devices
Quantity 229

Product Description

Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

Reason for Recall

Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

Distribution Pattern

Nationwide

Lot / Code Information

software version R1.2

Other Recalls from Philips Medical Systems Nederlands

Recall # Classification Product Date
Z-1240-2019 Class II Ingenia Ambition S (781359), Ingenia Ambition X... Mar 25, 2019
Z-1141-2019 Class II Foot Switches used with the following systems: ... Feb 19, 2019
Z-1140-2019 Class II Foot Switches used with Philips MultiDiagnost E... Feb 19, 2019
Z-0903-2019 Class II SmartPath to dStream for XR and 3.0T, Model Num... Dec 21, 2018
Z-0908-2019 Class II Intera 1.5T High Performance, Model Number 7812... Dec 21, 2018

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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