![]() 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. 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 System, x-ray, stationary - Product Code KPR You can download a raw copy of the database here.Class 2 Device Recall Philips Bucky Diagnost Always cite the International Consortium of Investigative Journalists when using this data. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. The same device may have different names in different countries. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Medical devices help to diagnose, prevent and treat many injuries and diseases. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. ![]()
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