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The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide Distribution - US Nationwide and the country of Canada.ġ A record in this database is created when a firm initiates a correction or removal action.

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In your 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.įurther questions please call (978) 687-1501. In your March 28, 2013, letter, you proposed a 6 month timeframe for this corrective action, and in your email, you communicated that the field corrections were ongoing and would be completed by July 16, 2013. You have also revised your IATD document to improve instructions to the field engineer for table height measurements. 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.

Field Service Engineer (FSE) will execute corrections and attach record to IATD file. Philips Healthcare issued an Urgent Field Safety Notification on January 11, 2013, to advised users of issued and perform corrective action to the units. Release of Material/Component prior to receiving test results This system is used for making x-ray exposures for diagnostics

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System, x-ray, stationary - Product Code KPR

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To attend this course, the service professional must have a good understanding of the principles gained through attending Phase II or two years equivalent experience in servicing RAD equipment.Class 2 Device Recall Philips Bucky Diagnost

M-Cabinet CXA (Generator, 65kW or 80kW).

System components that will be covered in this course include:

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The DigitalDiagnost product is built on the BuckyDiagnost platform and can have a Optimus Generator or an M-Cabinet CXA Generator.

The Diagnost course is a skills development course designed to provide the experienced service professional with the skills necessary to fully service and calibrate these single & dual detector systems. Continuing Education Servicing the Philips DigitalDiagnost & BuckyDiagnost Systems The Philips DigitalDiagnost (and BuckyDiagnost) training course covers Philips latest DR (Digital Radiography) system as well as the Bucky-based BuckyDiagnost system.

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