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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Digital Diagnost

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 Class 2 Recall
Philips Digital Diagnost
see related information
Date Posted June 17, 2013
Recall Status1 Open
Recall Number Z-1447-2013
Recall Event ID 64130
Premarket Notification
510(K) Number
K982795 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
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
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer 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
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Philips Heathcare issued an Urgent - Field Safety Notice letter dated January 11, 2013 to all affected customers to inform them of the systems afffected by this Field Action. The letter identified what the issue is, under what circumstances it may occur, the actions to take to avoid or minimize the occurrence of the issue and the actions planned by Philips to correct the issue. Customers were inform that if they have multiple BuckyDiagnost systems, they will be contacted by a Field Service Engineer to clarify which systems are affected. The Field Service Engineer (FSE) performs a full IATD (Installation PHILIPS Acceptance Test Document) and file the IATD record. Your proposed corrective action plan (CAP) for the Bucky Diagnost system involves two mandatory field actions including new testing for sites with missing documentation and correcting the table height measurements for systems where the incorrect measurement procedure was used. You have also revised your IATD document to improve instructions to the field engineer for table height measurements. In your March 28, 2013, letter, you proposed a 6 month timeframe for this corrective action, and in your May 9, 2013 email, you communicated that the field corrections were ongoing and would be completed by July 16, 2013. In your May 9, 2013 email, you also clarified that the recalls are to be completed free of charge to any affected customer, whether or not they have a service agreement with Philips Healthcare. For questions contact your local Philips representative. 1-800-722-9377.
Quantity in Commerce 177 units
Distribution Worldwide Distribution - USA Nationwide and the country of Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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