Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Phi...
FDA Device Recall #Z-2156-2012 — Class II — July 11, 2012
Recall Summary
| Recall Number | Z-2156-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 11, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Healthcare Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 41 units |
Product Description
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Reason for Recall
When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
Distribution Pattern
Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom
Lot / Code Information
US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278
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-1964-2013 | Class II | Philips Healthcare MobileDiagnostwDR system. M... | Jun 11, 2013 |
| Z-1189-2013 | Class II | HeartStart MRx Monitor/Defribillator; Product C... | Apr 8, 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.