Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity

FDA device recall Z-0674-2013 · posted 2013-01-15 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.

Action taken

The firm, Philips Healthcare, sent an 'URGENT- Medical Device Correction" letters' dated November 15, 2012, and December 3, 2012, to their customers. Both letters describe the product, problem and actions to be taken. The letters state that Philips is notifying all affected customers of this information via a 'Field Safety Notice and will be installing a software update on the affected Brilliance 64 and Ingenuity CT system in order to address these issues. A Philips' Field Service Engineer will be contacting each customer site and make arrangements to install the necessary software update on these device systems. The customers should contact their local Philips representative or local Philips Healthcare office. In North America and Canada needing further information or support concerning this update, should contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5, and enter their site ID or follow the prompts.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)

Distribution

Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.

Date initiated

2012-12-03

Date posted

2013-01-15

Date terminated

2013-06-18

Location

Cleveland, OH

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