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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance iCT and iCT SP

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 Class 2 Recall
Brilliance iCT and iCT SP
see related information
Date Posted May 30, 2012
Recall Status1 Terminated on February 26, 2013
Recall Number Z-1688-2012
Recall Event ID 61858
Premarket Notification
510(K) Number
K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
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.
Code Information Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Consumer Instructions No consumer action necessary
For Additional Information Contact Kumudini J. Carter
440-483-3032
Manufacturer Reason
for Recall
On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Philips Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated May 8, 2012 to all affected customers. The letter identifies the product and problem. No action is required by the customers. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Philips Healthcare will inspect the cooling units on all iCT and iCT SP systems for this issue and if the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge.
Quantity in Commerce 372
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VT, WA and WV and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Indonesia, Iraq, ISRAEL, Italy, Japan, Jordan, Korea, Lebanon, Mexico, Netherlands, New Zealand , Norway, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates and Uzbekistan.
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.
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