Brilliance 64 728231 Computed Tomography X-ray systems recall: Software Issue

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

4001, 4016, 9056, 9071, 9074, 9099, 9112, 9134, 9194, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9607, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9656, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10307, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10540, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 90224, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 95439, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95526, 95538, 95542, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 95691, 95707, 95811, 6003368, 95341A

Product

Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray…

Recalling firm

Philips Medical Systems (Cleveland) Inc

Quantity

184

Distribution

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Recall date

December 14, 2016

Classification

Class II

Status

Terminated

Agency

FDA (device)