Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product ...
FDA Device Recall #Z-1964-2013 — Class II — June 11, 2013
Recall Summary
| Recall Number | Z-1964-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 11, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Healthcare Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 240 systems US -- 1 system within Puerto Rico |
Product Description
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Reason for Recall
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Distribution Pattern
US Nationwide Distribution including Puerto Rico
Lot / Code Information
System Code - 712001
Other Recalls from Philips Healthcare Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2059-2013 | Class II | Philips Easy Upgrade DR, Code No: 712086 Thi... | Aug 8, 2013 |
| Z-1780-2013 | Class II | Radiohead Access Point 1.4 GHz Radiohead Access... | Jul 8, 2013 |
| Z-1797-2013 | Class II | Philips HeartStart MRx Monitor/Defibrillator, ... | Jun 19, 2013 |
| Z-1189-2013 | Class II | HeartStart MRx Monitor/Defribillator; Product C... | Apr 8, 2013 |
| Z-1783-2014 | Class II | Philips IntellVue Info Center iX 866023; PIIC i... | Mar 5, 2013 |
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.