2 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 13, 2022