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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85746

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 30, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

System, Tomography Computed Emmission

Z-2258-2020
Recall number
Z-2258-2020
Initiated
November 30, 2018
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
526 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

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.

Distribution pattern

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.

device · product 2 of 2

System, Tomography Computed Emmission

Z-2259-2020
Recall number
Z-2259-2020
Initiated
November 30, 2018
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
526 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model for Discovery NM 530c: 5248934, 5166674-01, H3000SA, H3001JA, H3001JD. Serial Numbers: 19016,0000000ME11041,19069,19098,19082,19070,19086,19027,19044,19083,19065,19062,19048,19009,19109,19015,19040,19085,19012, 19108, 19030, 19057,000000109961-1,19002,16001,16007,19008,19097,19072,19080,16020,19026,19005,19025,0000000000ME-4.

Distribution pattern

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.