—#115395

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K945278
Affected lot / code info: 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

Why it was recalled

An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2013-01-16
Posted by FDA: 2013-06-17
Terminated: 2013-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.