Z-0707-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2019
- Initiation Date
- November 30, 2018
- Termination Date
- September 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171
Product Description
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Reason for Recall
Improper design or specifications.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom
Code Information
Material Number: 10532746 - Serial #'s: 94401, 94405, 94406, 94408, 94409, 94413, 94414, 94415, 94420, 94421, 94422, 94423, 94424, 94425, 94426, 94427, 94429, 94430, 94431, 94432, 94433, 94434, 94435, 94436, 94438, 94440, 94441, 94442, 94443, 94444, 94445, 94447, 94448, 94451, 94452, 94457, 94459, 94460, 94461, 94462, 94463, 94464, 94466, 94467, 94473, 94476, 94477, 94480, 94481, 94482, 94483, 94484, 94485, 94487, 94491, 94492, 94493, 94495, 94496, 94497, 94498, 94499, 94500, 94502, 94504, 94505, 94506, 94508, 94510, 94512, 94513, 94516, 94517, 94518, 94519, 94520, 94521, 94522, 94525, 94530, 94531, 94532, 94533, 94534, 94537, 94538, 94540, 94541, 94542, 94543, 94547, 94549, 94550, 94551, 94555, 94556, 94558, 94559, 94560, 94562, 94563, 94565, 94566, 94567, 94569, 94574, 94576, 94580, and 94590 Material Number: 10532748 - Serial #'s: 94402, 94407, 94410, 94412, 94416, 94417, 94418, 94419, 94428, 94446, 94449, 94450, 94453, 94454, 94455, 94456, 94465, 94470, 94471, 94472, 94475, 94478, 94479, 94486, 94488, 94489, 94490, 94494, 94501, 94503, 94507, 94524, 94527, 94528, 94536, 94539, 94544, 94546, 94548, 94552, 94554, 94557, 94561, 94575, 94585, 94587, and 94593