Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7

FDA device recall Z-0334-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.

Action taken

Philips Healthcare released a 'Field Change Order' (FCO #72800531) on September 12, 2011. Philips sent an - URGENT Medical Device Correction letter dated October 17, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to this situation. The letter informed customers on how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update is installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. Customers were instructed to contact their Philips representative or local Philips Healthcare Office for further information or support for this issue. For North America and Canada customers were instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

Two (2) units were distributed.

Distribution

Worldwide Distribution - USA including Texas and the countries of Italy, India and China.

Date initiated

2011-09-22

Date posted

2011-12-01

Date terminated

2013-02-22

Location

Cleveland, OH

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