Recall Z-2258-2020 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
System, Tomography Computed Emmission
| Date | Jun 3, 2020 (initiated Nov 30, 2018) |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software. |
| Quantity | 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, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051855 | VENTRI Ge Medical Systems F.I. Haifa, Aug 2, 2005 |