Z-0009-2017 Class II Terminated
Recalled by Philips Medical Systems
— Cleveland, OH
FDA device recall Z-0009-2017 was initiated by Philips Medical Systems on August 24, 2016 and is designated Class II. Reason for recall: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstru… The recall status is terminated (terminated July 2, 2018). Affected quantity: 185.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- August 24, 2016
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185
Product Description
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason for Recall
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
Code Information
4001, 4016, 5169, 9056, 9071, 9074, 9099, 9112, 9134, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9565, 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, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9993, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29015, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 94539, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95538, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 123029, 95691, 95707, 95811, 122921, 122921, 123092, 123096, 123116, 123117, 6003368, 95341A