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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 Posted June 17, 2013
Recall Status1 Terminated 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/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
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 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 = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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