Recall Z-1078-2013 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
| Date | Apr 10, 2013 (initiated Mar 6, 2012) |
| Status | Terminated |
| Reason | Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators. |
| Root cause | Process control |
| Action | GE Healthcare sent an " IMPORTANT PRODUCT INFORMATION" letter dated March 6, 2012. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology/Cardiology. The letter described the Issue, instructions, Affected Product Details, and Product Correction. For questions contact your local GE Healthcare Service Representative or call the GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other Countries 262-896-2890. |
| Quantity | 2180 |
| Distribution | Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE |
| FDA record | Open on fda.gov |