GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Cam
FDA device recall Z-1078-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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, PA
- Date initiated
- 2012-03-06
- Date posted
- 2013-04-10
- Date terminated
- 2014-01-27
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K052434) | GE Medical Systems | 2005-09-27 |
| GE QUASAR NUCLEAR MEDICINE SYSTEM (K022960) | Ge Medical Systems F.I. Haifa | 2002-09-19 |
| HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K991841) | Ge Medical Systems F.I. Haifa | 1999-08-26 |