Brilliance BigBore Radiology 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.
This recall has been terminated (originally issued March 24, 2016).
- Recall Initiated
- March 24, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-2368-2016
- Quantity
- 17 units
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Software defect causing intermittently slow response of Host.
Distribution
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.
Lot / Code Info
Model #: 728244; Serial #s: 7052, 7172, 7200, 7244, 7252, 7375, 7380, 7384, 7390, 7514, 7533, 7546, 7614, 7633, 7708, 7781, 7789.
Root Cause
Software change control
Action Taken
On 3/24/2016 the firm mailed Customer Information letters to their customers.