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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 Device Recall Philips Digital Diagnost see related information
Date Initiated by Firm January 16, 2013
Date Posted June 17, 2013
Recall Status1 Open3, Classified
Recall Number Z-1447-2013
Recall Event ID 64130
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips Diagnost Stationary Radiographic System
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/
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.