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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64694
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-09
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 19036 19058 16006 19151 19091 16013 19049 19073 19059 19016 0000000ME11041 19027 19062 19012 19030 16001 19097 19072 19035 19043 16014 19032 19020 19022 16004 16009 19053 16008 19093 19004 19029 19076 19050 16002 19019 19006 19038 16005 00000000VEN002 11021 0000000 VEN005 11039 11019 11001 11027 11008 11031 11028 11046 11038 11015 11045 11044 11043 11025 11018 11030 11033 11022 11026 11002 11003 11029 11032 11009 11020 11007 00000000VEN003 11010 11037 11013 11005 11041 11040 11006 00000000VEN004 11138 11220 11093 11294 11801 11228 11251 11253 11248 11209 11247 11193 11262 11214 11261 11054 11189 11092 11244 11260 11087 11255 11359 11231 11059 11237 11303 11212 11300 11417 11397 11391 11389 11232 11263 11210 11213 11208 11023 11290 11215 11091 11252 11245 11072 11219 11394 11205 11202 11225 11049 11131 11156 11242 11292 11243 11291 11102 11108 11298 11319 11250 11254 11384 11258 11257 11035 11114 000E3GT08064A6 0000E3GT09163A 0000E3GT08038A 0000INDNVC0041 0000E3GT10189A 0000E3GT09136A 11075 11430 11137 11154 11233 11052 11322 11301 11286 11078 11327 11125 11152 11387 11337 11396 11288 11147 11395 11427 11328 11450 11128 11471 11165 11424 11448 11421 11332 11203 11468 11363 11069 11127 11284 11124 11229 11297 11190 11204 11306 11061 11161 11151 11441 11067 11336 11435 11077 11191 11497 11206 11192 11211 11085 11325 11222 11392 11169 11347 11166 11050 11470 11464 11280 11469 11376 11310 11119 11501 11076 11086 11140 11366 11178 11495 11383 11352 11345 11358 11223 11183 11422 11004 11307 11107 11074 11293 11276 11270 11218 11142 11145 11060 11170 11188 11431 11088 11275 11462 11465 11117 11179 11414 11150 11149 11455 11089 11374 11056 11453 11017 11279 11146 11324 11320 11360 11371 11385 11467 11273 11266 11230 11353 11409 11349 11101 11148 11315 11410 11461 11228 11443 11123 11090 11082 11438 11287 11454 11491 11065 11080 11084 11269 11299 11130 11043 11278 11053 11070 11122 11098 11393 11024 11466 11372 11234 11180 11063 11096 11051 11485 11340 11334 11095 11490 11309 11403 11330 11194 11173 11162 11134 11277 11402 11066 11167 11172 11164 11308 11226 11426 11445 11282 11404 11196 11181 11227 11264 11267 11415 11333 11311 11185 11289 11304 11331 11412 11346 11405 11444 11369 11224 11221 11344 11439 11436 11182 11118 11449 11423 11356 11478 11494 11246 11058 11105 11100 11475 11472 11486 11201 11113 11474 11109 11296 11357 11272 11312 11159 11121 11463 11406 11487 11271 11437 11321 11216 11377 11132 11458 11133 11502 11317 11314 11064 11195 11305 11452 11492 11316 11062 11382 11055 11103 11400 11429 11432 11433 11373 11323 11342 11281 11129 11097 11368 11171 11350 11268 11481 11186 11476 11110 11388 11295 11168 11106 11425 11120 11184 11256 11157 11155 11313 11177 11335 11379 11459 11329 11217 11198 11440 11413 11187 11265 1 11338 11199 11362 11083 11200 11259 11381 11016 11380 11408 11111 11285 11135 11480 11354 11428 11401 11447 11163 11411 11416 11446 11160 11419 11384 11249 11238 11240 11141 11241 11434 11483 11456 11274 11207 11375 11035 11114 11115 11318 11339 11048 11176 16017 19098 19070 19086 19044 19083 19056 19048 19009 19040 19002 16007 19080 16020 19026 19025 19024 16019 19052 19047 19003 19007 19001 16015 19042 19100 19017 16010 16011 19063 19037 19011 19095 19092 19094 19077 19067 19039 19021 19023 19031 19084 19013 19028 19088 19046 19014 16016 19085 19068 19033 Class II GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically. 556 Z-1168-2013
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