Device product
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
Z-0508-2015
Product summary
- Event
- Event 67869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 247 in US, 1 in Puerto Rico
- Official record key
device-enforcement:Z-0508-2015
Official wording
Reason: In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
Code information: Serial Numbers: SN12000024, SN12000166 , SN13000081 , SN13000127 , SN13000140 , SN13000141 , SN13000143 , SN13000144 , SN13000145 , SN13000167 , SN13000168 , SN13000169 , SN13000196 , SN13000199 , SN13000200 , SN13000201 , SN13000202 , SN13000203 , SN13000204 , SN13000205 , SN14000002 , SN14000004 , SN14000005 , SN14000006 , SN14000008 , SN14000009 , SN14000010 , SN14000011 , SN14000013 , SN14000014 , SN14000015 , SN14000016 , SN14000017 , SN14000019 , SN14000022 , SN14000024 , SN14000026 , SN14000028 , SN14000030 , SN14000031 , SN14000032 , SN14000033 , SN14000038 , SN14000041 , SN14000046 , SN14000047 , SN14000048 , SN13000153 , SN13000171 , SN13000155 , SN13000165 , SN13000187 , SN13000170 , SN13000176 , SN13000139 , SN13000189 , SN7369686 , SN13000150 , SN13000186 , SN13000197 , SN13000152 , SN13000162 , SN13000163 , SN14000012 , SN11000018 , SN13000136 , SN13000137 , SN13000138 , SN13000147 , SN13000154 , SN13000156 , SN13000159 , SN13000160 , SN13000164 , SN13000172 , SN13000175 , SN13000181 , SN13000188 , SN13000191 , SN13000194 , SN14000027 , SN130000184 , SN13000132 , SN13000146 , SN13000148 , SN13000149 , SN13000151 , SN13000161 , SN13000174 , SN13000177 , SN13000179 , SN13000179 , SN13000180 , SN13000183 , SN13000185 , SN13000190 , SN13000193 , SN13000206 , SN14000003 , SN14000023 , SN14000036 , SN11000001 , SN11000002 , SN11000003 , SN11000004 , SN11000005 , SN11000006 , SN11000007 , SN11000008 , SN11000009 , SN11000010 , SN11000011 , SN11000012 , SN11000013 , SN11000014 , SN11000014 , SN11000015 , SN11000016 , SN11000017 , SN11000020 , SN11000021 , SN11000021 , SN11000022 , SN11000023 , SN11000024 , SN11000025 , SN11000026 , SN11000027 , SN11000028 , SN11000029 , SN11000030 , SN11000031 , SN11000032 , SN11000033 , SN11000034 , SN11000035 , SN11000036 , SN11000037 , SN11000039 , SN11000040 , SN11000041 , SN11000042 , SN11000044 , SN11000045 , SN11000046 , SN11000047 , SN11000048 , SN11000048 , SN11000049 , SN11000050 , SN11000051 , SN11000052 , SN11000054 , SN11000055 , SN11000056 , SN11000057 , SN11000058 , SN11000059 , SN11000060 , SN11000061 , SN11000062 , SN11000063 , SN11000064 , SN11000065 , SN11000066 , SN11000067 , SN11000068 , SN11000069 , SN11000070 , SN11000071 , SN11000072 , SN11000073 , SN11000074 , SN11000075 , SN11000076 , SN11000077 , SN11000078 , SN11000079 , SN11000080 , SN11000081 , SN11000082 , SN11000083 , SN11000084 , SN12000002 , SN12000003 , SN12000004 , SN12000005 , SN12000006 , SN12000007 , SN12000008 , SN12000009 , SN12000010 , SN12000012 , SN12000013 , SN12000014 , SN12000015 , SN12000016 , SN12000018 , SN12000019 , SN12000020 , SN12000021 , SN12000022 , SN12000023 , SN12000025 , SN12000026 , SN12000027 , SN12000028 , SN12000029 , SN12000030 , SN12000031 , SN12000032 , SN12000033 , SN12000034 , SN12000035 , SN12000036 , SN12000037 , SN12000038 , SN12000039 , SN12000040 , SN12000041 , SN12000042 , SN12000043 , SN12000044 , SN12000045 , SN12000046 , SN12000047 , SN12000048 , SN12000049 , SN12000050 , SN12000051 , SN12000052 , SN12000053 , SN12000054 , SN12000055 , SN12000056 , SN12000057 , SN12000058 , SN12000059 , SN12000060 , SN12000061 , SN12000062 , SN12000063 , SN12000064 , SN12000065 , SN12000066 , SN12000067 , SN12000068 , SN12000069 , SN12000070 , SN12000071 , SN12000072 , SN12000073 , SN12000074 , SN12000075 , SN12000076 , SN12000077 , SN12000078 , SN12000079 , SN12000080 , SN12000081 , SN12000082 , SN12000083 , SN12000083 , SN12000084 , SN12000085 , SN12000086 , SN12000087 , SN12000088 , SN12000089 , SN12000090 , SN12000091 , SN12000092 , SN12000093 , SN12000094 , SN12000095 , SN12000098 , SN12000099 , SN12000100 , SN12000101 , SN12000102 , SN12000103 , SN12000104 , SN12000105 , SN12000106 , SN12000107 , SN12000108 , SN12000109 , SN12000110 , SN12000111 , SN12000112 , SN12000113 , SN12000114 , SN12000115 , SN12000116 , SN12000117 , SN12000118 , SN12000119 , SN12000120 , SN12000121 , SN12000122 , SN12000123 , SN12000124 , SN12000125 , SN13000001 , SN13000002 , SN13000004 , SN13000005 , SN13000006 , SN13000007 , SN13000008 , SN13000010 , SN13000011 , SN13000012 , SN13000013 , SN13000014 , SN13000015 , SN13000016 , SN13000017 , SN13000018 , SN13000019 , SN13000020 , SN13000021 , SN13000022 , SN13000023 , SN13000025 , SN13000026 , SN13000027 , SN13000028 , SN13000029 , SN13000030 , SN13000031 , SN13000032 , SN13000033 , SN13000034 , SN13000035 , SN13000036 , SN13000037 , SN13000038 , SN13000039 , SN13000040 , SN13000041 , SN13000042 , SN13000043 , SN13000044 , SN13000045 , SN13000046 , SN13000047 , SN13000048 , SN13000049 , SN13000050 , SN13000051 , SN13000052 , SN13000053 , SN13000054 , SN13000055 , SN13000056 , SN13000057 , SN13000058 , SN13000059 , SN13000060 , SN13000061 , SN13000062 , SN13000063 , SN13000064 , SN13000065 , SN13000066 , SN13000067 , SN13000069 , SN13000070 , SN13000071 , SN13000072 , SN13000073 , SN13000074 , SN13000075 , SN13000076 , SN13000077 , SN13000078 , SN13000079 , SN13000080 , SN13000082 , SN13000083 , SN13000084 , SN13000085 , SN13000086 , SN13000087 , SN13000088 , SN13000089 , SN13000090 , SN13000091 , SN13000092 , SN13000093 , SN13000094 , SN13000095 , SN13000096 , SN13000097 , SN13000098 , SN13000099 , SN13000100 , SN13000101 , SN13000102 , SN13000103 , SN13000104 , SN13000105 , SN13000106 , SN13000107 , SN13000108 , SN13000109 , SN13000110 , SN13000111 , SN13000112 , SN13000113 , SN13000114 , SN13000115 , SN13000116 , SN13000117 , SN13000118 , SN13000119 , SN13000120 , SN13000121 , SN13000122 , SN13000123 , SN13000124 , SN13000124 , SN13000125 , SN13000126 , SN13000128 , SN13000129 , SN13000130 , SN13000131 , SN13000133 , SN13000134 , SN13000135 , SN13000157 , SN13000173 , SN13000178 , SN13000182 , SN13000192 , SN13000198 , SN14000007 , SN14000018 , SN14000021 , SN14000025. Four systems were delivered to foreign (non-US) countries that do not have serial numbers.
Distribution pattern: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI.,and the countries of : Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iraq, Ireland, Italy, Jordan, Liberia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.