The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the bo

FDA device recall Z-1791-2012 · posted 2012-06-08 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

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

Date initiated

2012-05-07

Date posted

2012-06-08

Date terminated

2013-07-25

Location

Cleveland, OH

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