Recall Z-1168-2013 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
| Date | Apr 24, 2013 (initiated Jan 9, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically. |
| Root cause | Device Design |
| Action | Consignees were sent on 1/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated January 9, 2013. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology / Head of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. |
| Quantity | 556 |
| Distribution | Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, |
| FDA record | Open on fda.gov |