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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64:Computed Tomography Xray Systems,

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  Class 2 Device Recall Brilliance 64:Computed Tomography Xray Systems, see related information
Date Initiated by Firm February 05, 2016
Create Date April 08, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1354-2016
Recall Event ID 73338
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core 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
Code Information Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310287, 310288, 310289, 310290, 310291, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 333106, 333107, 333108, 333109, 333110, 333112, 333114, 333115, 333116, 333117, 333121, 52062, 52066, 52080, 52081 52082, 52083, 52084, 310286, 333004, 333111, 333113, 333118, 333119 & 333120.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly Wright Lee
440-483-2997
Manufacturer Reason
for Recall		 The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems sent a Customer Information dated February 5, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. To correct the issue Philips will release field change orders (FCO) 72800652 and 72800644 to install a software update on the affected systems. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts). For questions regarding this recall call 440-483-2997.
Quantity in Commerce 88
Distribution Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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