Philips Medical Systems (Cleveland) Inc: Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Recall number

Z-0845-2012

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Status

Terminated

Initiated

2011-10-07

Posted

2012-01-24

Terminated

2013-06-18

Reason

The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state

Root cause

Software design

Action

On 10/10/2011 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected products, the problem, the hazard involved, the action to be taken by the customer, and actions planned by Philips. Customers were to reboot their systems if the two possible scenarios occurred. Philips Healthcare plans on installing the update through a Field Change Order free of charge. For further information or support concerning the issue, contact a local Philips representative or local Philips Healthcare office. In North America and Canada, contact Customer Care Solutions Center at 1-800-722-9377, option 5.

Quantity

548 units

Distribution

Worldwide Distribution -- USA, including the states of: AL, AZ, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA & WV and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BANGLADESH, BELGIUM, Brazil, CHINA, COLUMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LUXEMBOURG, MALAYSIA, MALI, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, QATAR, RUSSIA, SINGAPORE, SLOVENIA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN & VIETNAM.

Lot, serial or model codes

Model #'s - Brilliance 64: 728231, Ingenuity CT: 728326, iCT: 728306; iCT SP: 728311 & Brilliance Big Bore: 728243

510(k) numbers

["K033326","K033357","K060937"]

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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