System, Tomography Computed Emmission recallZ-2259-2020 · GE Healthcare, LLC · initiated Nov 30, 2018
Class II Open, Classified All recalls posted in June 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.
Recall details
- Recall number
- Z-2259-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2018
- Posted by the FDA
- Jun 3, 2020
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 526 total units
- Product code
- KPS
- FDA submissions
- K080124
- 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 description
System, Tomography Computed Emmission
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K080124 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Discovery NM 530c H3000SAG E Medical Systems Israel Ltd. · System, tomography, computed, emission1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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