Philips Medical Systems (Cleveland) Inc: Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Recall number

Z-0674-2013

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Status

Terminated

Initiated

2012-12-03

Posted

2013-01-15

Terminated

2013-06-18

Reason

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.

Root cause

Software design

Action

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.

Quantity

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.

Lot, serial or model codes

Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .

510(k) numbers

["K033326"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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