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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 Recall
Philips Digital Diagnost
see related information
Date Posted June 17, 2013
Recall Status1 Open
Recall Number Z-1448-2013
Recall Event ID 64130
Premarket Notification
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, Massachusetts 01810
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: 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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