Reported Dec 24, 2014 · Terminated
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- 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.
- Lot codes and dates
- Serial NumbersSN12000024, 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
- Amount recalled
- 247 in US, 1 in Puerto Rico
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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