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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-1448-2013
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:
316235
335517
321739
334582
359767
357879
344896
351321
356953
365640
365639
359449
363674
375601/SN0802006
368428
7272440
372848
373508
375366
396836/SN0802372
382140/SN0702475
381883/SN0802010
393931/SN0802399
396572/SN0802281
392502/SN0802179
390113/SN0802451
386784/SN0802264
381098/SN0802124
390098/SN0802242
382018/SN0802118
9000529
373499/SN0802249
383639/SN0802099
390129/SN0802521
404296/SN0802460
404298/SN0802474
416255/SN0902004
802119
409788/SN0802635
406492/SN0802489
390393/SN0802337
399024/SN0802562
402837/SN0802410
408716/SN0802551
408239/SN0802583
408240/SN0802630
408236/SN0802554
406024/SN0802481
408591
406156/SN0802537
406140/SN0802479
407675/SN0802517
408967/SN0802547
414087/SN08000100
435757/SN09000361
422092/SN0902023
415783/SN0802662
422536/SN09000199
416904/SN08000052
421962/SN09000054
429129/SN09000365
426287/SN09000096
430908/SN09000165
441638/SN09000356
456404/SN10000212
435210/SN0902204
435924/SN09000281
438069/SN09000278
439920/SN09000329
443660/SN10000010
449005/SN10000094
443235/SN09000450
448008/SN10000043
455848/SN10000351
455621/SN10000163
455622/SN10000164
449232/SN10000248
449364/SN10000078
449365/SN10000110
451680/SN10000202
457265/SN10000417
475767/SN11000387
453200/SN10000133
452170/SN10000401
453201/SN10000124
466031/SN11000053
459498/SN10000231
464880/SN10000714
464350/SN10000589
470908/SN11000183
485692/SN11000443
470803/SN10000667
475846/SN11000269
477673/SN11000278
478112/SN11000163
478232/SN11000216
480052/SN11000286
480053/SN11000288
487808/SN11000526
488714/SN11000572
492704/SN11000641

Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall
Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
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 101 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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