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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-1952-2026 - Philips Achieva 1.5T Initial system with MR Elastography (MRE).
1. Model Number (REF): 781178.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1951-2026 - Philips Achieva 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781196.
2. Model Number (REF): 781296.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1953-2026 - Philips Achieva 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781278.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1954-2026 - Philips Evolution Upgrade 1.5T with MR Elastography (MRE).
1. Model Number (REF): 782116
2. Model Number (REF): 782148.
3. Model Number (REF): 782166.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1955-2026 - Philips Evolution upgrade 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782143.
2. Model Number (REF): 782162.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1957-2026 - Philips Ingenia 1.5T CX with MR Elastography (MRE).
1. Model Number (REF): 781262.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1956-2026 - Philips Ingenia 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781315.
2. Model Number (REF): 781341.
3. Model Number (REF): 781396.
4. Model Number (REF): 782115.
510(k) ...
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1959-2026 - Philips Ingenia 3.0T CX with MR Elastography (MRE).
1. Model Number (REF): 781271.
2. Model Number (REF): 782105.
510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K2...
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1958-2026 - Philips Ingenia 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781342.
2. Model Number (REF): 781377.
3. Model Number (REF): 782103.
510(k) Numbers: K163116, K173079, K183063,...
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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Z-1960-2026 - Philips Ingenia Ambition S with MR Elastography (MRE).
1. Model Number (REF): 781359.
2. Model Number (REF): 782108.
3. Model Number (REF): 782139.
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2
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04/27/2026
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FEI # 3006648320 Philips North America
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