Intended for both adult and pediatric patients for recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities…

Recalling firm

Philips Medical Systems, Inc.

Quantity

247 in US, 1 in Puerto Rico

Distribution

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.

Recall date

December 24, 2014

Classification

Class II

Status

Terminated

Agency

FDA (device)