System, Tomography Computed Emmission
FDA device recall Z-2259-2020 · posted 2020-06-03 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- KPS
- Quantity affected
- 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 Distribut
- Date initiated
- 2018-11-30
- Date posted
- 2020-06-03
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTRI 1.1 (K080124) | Ge Medical Systems F.I. Haifa | 2008-01-31 |