Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 70...
FDA Device Recall #Z-1449-2013 — Class II — January 16, 2013
Recall Summary
| Recall Number | Z-1449-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 16, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Healthcare Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 66 units |
Product Description
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
Reason for Recall
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
Distribution Pattern
Worldwide Distribution - US Nationwide and the country of Canada.
Lot / Code Information
Serial Numbers: 335292 351085 351326 348891 348895 353313 358016 359426 370503 354382 354749 369640 380748 356820 362256 357699 362257 357255 358489 380361 363543 362719 363669 363544 363305 363538 365150 364211 379698 380749 375725 375727 375729 377144 381880 381881 380798/SN07000617 381877 383767/SN07000639 392883/SN08000099 394519/SN08000135 421035/SN09000031 396577/SN08000190 402575/SN08000382 397513/SN08000185 407681/SN08000345 411751/SN08000438 410786/SN08000454 417251/SN08000547 427833/SN09000208 415998/SN08000511 416000/SN08000508 421979/SN09000098 422100/SN09000216 442036/SN09000336 448226/SN09000416 455130/SN10000286 462191/SN10000266 468071/SN10000398 467831/SN10000326 471707/SN11000023 477922/SN11000076 481951/SN11000205 489697/SN11000261
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.