Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 T

FDA device recall Z-1449-2013 · posted 2013-06-17 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

Action taken

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

KPR

Quantity affected

66 units

Distribution

Worldwide Distribution - US Nationwide and the country of Canada.

Date initiated

2013-01-16

Date posted

2013-06-17

Date terminated

2013-10-15

Location

Andover, MA

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