Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X...

FDA Device Recall #Z-0612-2019 — Class II — November 7, 2018

Recall Summary

Recall Number Z-0612-2019
Classification Class II — Moderate risk
Date Initiated November 7, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems Gmbh, DMC
Location Hamburg, N/A
Product Type Devices
Quantity 146

Product Description

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Reason for Recall

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Lot / Code Information

All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Other Recalls from Philips Medical Systems Gmbh, DMC

Recall # Classification Product Date
Z-2357-2021 Class II CombiDiagnost R90 Software Version R1.0 and R1.1 Jul 22, 2020
Z-1329-2020 Class II CombiDiagnost PCF, Software v. 1.0.5, Product C... Dec 19, 2019
Z-1328-2020 Class II CombiDiagnost GCF, Software v. 1.0.5, Product C... Dec 19, 2019
Z-0239-2019 Class II Philips DigitalDiagnost software 4.1.x and 4.2.... Sep 19, 2018
Z-2858-2018 Class II DigitalDiagnost Dual Detector (Stitching Patien... Jun 27, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.