Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore 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.
FDA Recall Z-0791-2014 · Posted 2014-01-29
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2011-03-07
Date Terminated2014-04-28
Product Quantity23
Reason for Recall
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
Firm Action
Philips Medical Systems sent a Field Safety Notice letter dated February 25, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers.
Your Corrective Action Plan (CAP) is approved and consists of:
1. Notifying all affected users with Field Safety Notice 72800527/72800528 starting March 8, 2011. This Field Safety Notice has been reviewed and is approved.
2. Following up with all responses by dispatching a Field Service engineer to each site to install the software update at no cost to the user.
3. Tracking the responses from users by certified mail.
For further questions please call (440) 483-7600.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.