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U.S. Department of Health and Human Services

Class 2 Device Recall Ventri Discovery NM 530c

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 Class 2 Device Recall Ventri Discovery NM 530c see related information
Date Posted April 24, 2013
Recall Status1 Terminated on August 06, 2013
Recall Number Z-1168-2013
Recall Event ID 64694
510(K)Number K051855  K080124 
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
Code Information 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
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action Consignees were sent on 1/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated January 9, 2013. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology / Head of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
Quantity in Commerce 556
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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