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.