FDA Device recall Z-2258-2020

System, Tomography Computed Emmission

FDA Device
Class II
ongoing
Published 2020-06-10

On 2020-06-10 the FDA classified a Class II recall of System, Tomography Computed Emmission by Ge Healthcare, citing 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 du….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2258-2020
Classification	Class II
Status	ongoing
Initiated	2018-11-30
Published	2020-06-10
Last updated	2026-09-13 11:55 UTC
Company	Ge Healthcare
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, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV

Product

System, Tomography Computed Emmission

Reason

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.

Identifiers

code_info	Model for Ventry: ASM001605, H3000YT, H3000YW, H3000YY, H3000ZW Serial Numbers: 11075,11430,11137,11154,11138,11512… 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, 11324,11146,11312,11320,19030,11272,11360,11371,11385,11467,11231,11511,11

code_info

Model for Ventry: ASM001605, H3000YT, H3000YW, H3000YY, H3000ZW Serial Numbers: 11075,11430,11137,11154,11138,11512…

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, 11324,11146,11312,11320,19030,11272,11360,11371,11385,11467,11231,11511,11

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2258-2020%22

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