CLASS II ONGOING Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
System, Tomography Computed Emmission recalled by GE Healthcare
GE Healthcare is recalling System, Tomography Computed Emmission, distributed in 40 states. The recall was initiated on 30 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2258-2020
- FDA event ID
- 85746
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Nov 2018
- FDA classified
- 3 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Nov 2018 | Recall initiated by company | |
| 3 Jun 2020 | Classified by FDA | +551 days |
| 10 Jun 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
System, Tomography Computed Emmission
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Is System, Tomography Computed Emmission recalled?
Yes. GE Healthcare recalled System, Tomography Computed Emmission on 30 Nov 2018. The recall is Class II and its status is Ongoing. Recall number Z-2258-2020.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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