Z-1791-2012Class II

The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional...

Name: Z-1791-2012 The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-05-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-07 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray... on 2012-05-07. FDA classified it as Class II and gives the reason as "Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1791-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-06-08
Terminated: 2013-07-25
Recalling firm: Philips North America LLC
Product: The Brilliance iCT and iCT SP 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. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc
Root cause tag: software
FDA root cause: Software design
Action: Philips sent an Urgent - Medical Device Correction letter dated May 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Customers were instructed to review the Release Document provided them with information about the software update, new feature and enhancements. For North America and Canada customers should contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Side ID or follow the prompts. For questions regarding this recall call 440-483-4918.
Quantity in commerce: 241
Distribution: Worldwide Distribution - USA including AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA & WV and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, EGYPT, France, Germany, Greece, Hungary, ICELAND, India, Indonesia, Israel, ISRAEL, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, PHILIPPINES, POLAND, Portugal, Qatar, Russia, SINGAPORE, South Korea, SPAIN, SWEDEN, Switzerland, Taiwan, THAILAND, Turkey, UNITED KINGDOM & Uzbekistan.
Product codes and lots: Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1791-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1791-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-08

Product code JAK

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)