FDA Device recall Z-2259-2020
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-2259-2020 |
| 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 Discovery NM 530c: 5248934, 5166674-01, H3000SA, H3001JA, H3001JD. Serial Numbers: 19016,0000000ME11041…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. |
|---|
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-2259-2020%22
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