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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Brilliance CT system

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 Class 2 Recall
Philips Brilliance CT system
see related information
Date Posted January 29, 2014
Recall Status1 Terminated on April 28, 2014
Recall Number Z-0791-2014
Recall Event ID 66311
Premarket Notification
510(K) Numbers
K033326  K033357  K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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.
Code Information Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 23
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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