||June 17, 2013
|Recall Event ID
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
||Philips Diagnost Stationary Radiographic System
712020, 712022, 712050, 712052, 712055, 712057, 712062
Universal RAD Applications
|Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
|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.
|RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
||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
||Worldwide Distribution - USA Nationwide and the country of
|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)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.