Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055...
FDA Device Recall #Z-1447-2013 — Class II — January 16, 2013
Recall Summary
| Recall Number | Z-1447-2013 |
| 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 | 177 units |
Product Description
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Reason for Recall
Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used
Distribution Pattern
Worldwide Distribution - USA Nationwide and the country of Canada
Lot / Code Information
Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 461799/SN10000347 446047/SN09000440 449718/SN10000093 446665/SN09000451 461979/SN10000701 461976/SN10000704 456093/SN10000204 453385/SN10000383 451543/SN10000100 451542/SN10000098 445533/SN10000006 456179/SN10000274 487800/SN11000531 455752/SN10000200 456282/SN10000271 459772/SN10000294 463799/SN10000400 464863/SN10000533 463407/SN10000395 464755/SN10000391 472611/SN11000056 466808/SN10000464 464981/SN10000471 471148/SN11000122 471147/SN11000120 469133/SN10000572 469559/SN10000592 473817/SN11000108 477209/SN11000148 475235/SN11000119 471047/SN10000700 471066/SN10000696 471070/SN10000695 474089/SN11000079 479766/SN11000234 487719/SN11000538
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.