||June 17, 2013
||Terminated on October 15, 2013
System, X-Ray, Stationary - Product Code KPR
||Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system.
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics.
|Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
|An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
||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
||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.