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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-1449-2013
Recall Event ID 64128
510(K)Number K945278 
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system.

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


This system is used for making x-ray exposures for diagnostics.
Code Information Serial Numbers:
335292
351085
351326
348891
348895
353313
358016
359426
370503
354382
354749
369640
380748
356820
362256
357699
362257
357255
358489
380361
363543
362719
363669
363544
363305

363538
365150
364211
379698
380749
375725
375727
375729
377144
381880
381881
380798/SN07000617
381877
383767/SN07000639
392883/SN08000099
394519/SN08000135
421035/SN09000031
396577/SN08000190
402575/SN08000382
397513/SN08000185
407681/SN08000345
411751/SN08000438
410786/SN08000454
417251/SN08000547
427833/SN09000208
415998/SN08000511
416000/SN08000508
421979/SN09000098
422100/SN09000216
442036/SN09000336
448226/SN09000416
455130/SN10000286
462191/SN10000266
468071/SN10000398
467831/SN10000326
471707/SN11000023
477922/SN11000076
481951/SN11000205
489697/SN11000261
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
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
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 66 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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