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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 Posted June 17, 2013
Recall Status1 Open
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
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
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428232/SN0902049
415314/SN0902058
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399555/SN0802572
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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 MA 01810
978-687-1501
For Additional Information Contact
978-687-1501
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 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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