Philips DuraDiagnost stationary X-ray system
FDA Device Recall #Z-2682-2016 — Class II — September 17, 2015
Recall Summary
| Recall Number | Z-2682-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 17, 2015 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Philips Electronics North America Corporation |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 15 |
Product Description
Philips DuraDiagnost stationary X-ray system
Reason for Recall
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Distribution Pattern
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Lot / Code Information
SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093
Other Recalls from Philips Electronics North America Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0614-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Softw... | Nov 15, 2018 |
| Z-0592-2019 | Class II | IntelliVue MX40 Patient Monitor, Model Nos. 865... | Oct 10, 2018 |
| Z-3227-2018 | Class II | Allura Xper F010, System Code 722003 Vascul... | Jul 16, 2018 |
| Z-3218-2018 | Class II | INTEGRIS SUITE, System Code 722199 Vascular... | Jul 16, 2018 |
| Z-3215-2018 | Class II | INTEGRIS CV, System Code 722030 Vascular, c... | Jul 16, 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.