Z-2259-2020Class II

System, Tomography Computed Emmission

Name: Z-2259-2020 System, Tomography Computed Emmission
Creator: GE Healthcare, LLC
Published: 2018-11-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-11-30 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of System, Tomography Computed Emmission on 2018-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2259-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-30
Posted: 2020-06-03
Recalling firm: GE Healthcare
Product: System, Tomography Computed Emmission
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2259-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2258-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03
Z-2259-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03

Product code KPS

K080124Class IIVentri 1.1Ge Medical Systems F.I. Haifa / cleared 2008-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)