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.
Enforcement
- Recall Number
- Z-0508-2015
- Event ID
- 67869
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- April 8, 2014
- Classification Date
- December 16, 2014
- Termination Date
- May 31, 2018
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
Description
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.
In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
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.
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.
247 in US, 1 in Puerto Rico