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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Bucky Diagnost

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  Class 2 Device Recall Philips Bucky Diagnost see related information
Date Initiated by Firm January 16, 2013
Date Posting Updated June 17, 2013
Recall Status1 Terminated 3 on October 15, 2013
Recall Number Z-1450-2013
Recall Event ID 64128
510(K)Number K945278  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips BuckyDiagnost Radiographic.

Catalog Numbers:
704031, 704032, 704035, 704060, 704062

This system is used for making x-ray exposures for diagnostics
Code Information Serial Numbers:, 334584, 345869, 349805, 352617, 375957/SN07000650, 352645, 355617, 356954, 363678, 362217, 362252, 361021, 364214, 362429, 361526, 363545, 363802, 364816, 366510, 366090, 367504, 370290, 370643, 373506, 372845, 376998, 383090, 384688/SN07000603, 386397/SN07000659, 406161/SN08000556, 386265/SN08000415, 389969/SN08000090, 381103/SN08000131, 444254/SN09000380, 406491/SN08000315, 389383/SN08000100, 447038/SN10000169, 389970/SN08000092, 406017/SN08000307, 389972/SN08000080, 389656/SN08000052, 386679/SN08000051, 390255/SN08000050, 394368/SN08000196, 396406/SN08000193, 399529/SN08000297, 401268/SN08000268, 402249/SN08000323, 399571/SN08000559, 384510/SN07000618, 402246/SN08000261, 403330/SN08000296, 403648/SN08000292, 407890/SN08000377, 405887/SN08000381, 413307/SN08000521, 413205/SN08000562, 411311/SN08000528, 419318/SN09000042, 428504/SN09000200, 413818/SN08000526, 414461/SN08000518, 414601/SN08000501, 438511/SN10000166, 414315/SN08000474, 418205/SN08000568, 419316/SN09000007, 421970/SN09000058, 422097/SN09000068, 426137/SN09000109, 430918/SN09000175, 435194/SN09000234, 439546/SN09000334, 439739/SN09000346, 436337/SN09000251, 438835/SN09000295, 439098/SN09000294, 439817/SN09000318, 443072/SN09000363, 443231/SN09000368, 442855/SN09000357, 443453/SN09000378, 456506/SN10000167, 449719/SN10000034, 448152/SN10000013, 448150/SN10000072, 449717/SN10000068, 450554/SN10000096, 451156/SN10000059, 456283/SN10000272, 456082/SN10000174, 458580/SN10000196, 459495/SN10000212, 460074/SN10000260, 460485/SN10000228, 460757/SN10000290, 461677/SN10000302, 461229/SN10000218, 462389/SN10000252, 463385/SN10000344, 465974/SN10000320, 468064/SN10000347, 466164/SN10000336, 468078/SN11000032, 468518/SN10000353, 470291/SN10000374, 471046/SN10000386, 471701/SN11000054, 483054/SN11000246, 476276/SN11000045, 480210/SN11000126, 483867/SN11000298, 483244/SN11000199, 486144/SN11000217, 488176/SN11000244

Recalling Firm/
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
Manufacturer Reason
for Recall
An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
Action Philips Healthcare issued an Urgent Field Safety Notification on January 11, 2013, to advised users of issued and perform corrective action to the units. Field Service Engineer (FSE) will execute corrections and attach record to IATD file. 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. Further questions please call (978) 687-1501.
Quantity in Commerce 116 units
Distribution Worldwide Distribution - US 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.