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U.S. Department of Health and Human Services

Class 2 Device Recall Ventri

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  Class 2 Device Recall Ventri see related information
Date Initiated by Firm November 30, 2018
Date Posted June 03, 2020
Recall Status1 Open3, Classified
Recall Number Z-2258-2020
Recall Event ID 85746
510(K)Number K051855  
Product Classification System, tomography, computed, emission - Product Code KPS
Product System, Tomography Computed Emmission
Code Information Model for Ventry: ASM001605, H3000YT, H3000YW, H3000YY, H3000ZW  Serial Numbers: 11075,11430,11137,11154,11138,11512,11322,11093,11301,11286,11294,11021,11078,11125,11235,11387, 11337, 11288,11396,11147,11039,11427,11328,11471,11251,11424,11448,11421,11450,11203,11468,11363,19016,11069,11127,11284,11124,11229,11057,11143,11515,11190,11001,11027,11297,11306,11061,11151,11161,11441,11248,11067,11247, 11435, 11077, 11513, 11497,  11206,11211,11347,19069,11085,11392,11169,11222,11325,19098,19082,11398,11420,11378,11166,11008,11470,19070,19086,19027 19044,19083,19065,19062,11464,11280,11469,11376,11310,11119,11501,19048,11076,11086,11031,11366,11214,11383,19009,11345, 11358,11183,11422,11004,11307,11074,11503,11276,11054,11270,11189,11142,11244,11060,11145,11260,11092,11431,11038,11170,19109,19015,19040,11087,11462,11465,11117,19085,11179,11414,11150,19012,19108,11365,11255,11176,11089,11374,11017,11279,11359, 11324,11146,11312,11320,19030,11272,11360,11371,11385,11467,11231,11511,11505,11059,11045,11230,11353,11409,11349,11148,11315,11410,11044,11461,19057,11228,11443,11123,11237,11082,11090,11303,11438,11287,11454,11491,11065,11084,11080,11212,11269, 11489,11517,11043,11299,11300,11213,11278,11417,11053,11070,11122,11025,11098,11372,11391,11393,11397,11389,11232,11234, 11063,11180,19002,11018,11051,11096,11485,16001,16007,19008,19097,11095,11210,11490,11030,11033,11309,11022,11403,11330, 11340,11162,11442,11014,11407,11514,11277,11402,11066,11167,11164,11226,11426,11308,11445,11208,11282,11404,11304,11185, 11181,11227,11264,11267,11289,11415,11311,11333,11331,11026,11412,11023,11290,11346,11405,11482,11221,11224,11369,11002, 11003,11118,11444,11449,11344,11029,11439,11182,11436,11356,11423,11478,11494,11215,11246,19072,11058,19080,11105,11475, 11472,11486,11032,11201,11113,11474,11296,16020,11091,11357,11121,11159,11252,11463,11498,11406,11487,11271,11437,11321, 11009,11216,11377,11132,11458,11133,11367,11516,19026,11317,11064,11195,11072,11305,11452,11219,11316,11373,11492,19005, 11062,11382,11245,11314,11103,11394,11400,11429,11432,11433,11323,11342,11007,11205,11202,11281,11129,11225,11010,19025, 11097,11171,11350,11368,11049,11268,11131,11481,11186,11476,00000000VEN002, 0000E3GT09163A, 0000E3GT08038A, 00000000VEN003.     
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
FDA Determined
Cause 2		 Other
Action GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.
Quantity in Commerce 526 total units
Distribution Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Sweden, Taiwan, Thailand, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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