2 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·April 17, 2013
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025