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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2459-2024 - SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance
Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2484-2024 - SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2461-2024 - SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2462-2024 - 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
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2463-2024 - 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2464-2024 - Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2465-2024 - Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2466-2024 - SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2467-2024 - Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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Z-2468-2024 - Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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2
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08/02/2024
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GE Medical Systems, LLC
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