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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-2471-2024 - 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, 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-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-2477-2024 - Brivo MR355, with affected software versions: SV20.3, SV23.3, 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-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-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-2482-2024 - Discovery MR950, with affected software versions: 7T23.0; 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-2478-2024 - Optima MR360, with affected software versions: SV20.3, SV23.3, 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-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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Z-2483-2024 - SIGNA 7.0T, with affected software versions: 7T29.1, 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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