Retiro De Equipo (Recall) de Device Recall Philips Bucky Diagnost

Recall

64128

Class 2

Z-1449-2013

2013-01-16

2013-06-17

Terminated

United States

2013-10-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115395

An inspection shows several iatds (installation acceptance test could not be located or different templates have been used.

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.