Device product
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-2369-2016
Product summary
- Event
- Event 73750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 203 units
- Official record key
device-enforcement:Z-2369-2016
Official wording
Reason: Software defect causing intermittently slow response of Host.
Code information: Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.
Distribution pattern: Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Derived failure modes
-
Device software or design
Software defect