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FDAFDA · Food and drugs·Recall number Z-0508-2015

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.

Published December 24, 2014 · Recall initiated: April 8, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Medical Systems, Inc.
Distributor
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.
Lot
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 ,
Risk classification
Class II
Area (FDA)
device
Country
United States

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