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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-1969-2026 - Philips Upgrade to MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782130.
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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-1967-2026 - Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781270.
2. Model Number (REF): 782113.
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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-1966-2026 - Philips SmartPath to dStream for 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782145.
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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-1965-2026 - Philips SmartPath to dStream for 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781260.
2. Model Number (REF): 782112.
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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-1968-2026 - Philips SmartPath to Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 782118.
2. Model Number (REF): 782144.
3. Model Number (REF): 782163.
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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-1964-2026 - Philips MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782120.
2. Model Number (REF): 782153.
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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-1963-2026 - Philips Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 781358.
2. Model Number (REF): 782107.
3. Model Number (REF): 782136.
510(k) Numbers: K213516, K223458,...
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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-1962-2026 - Philips Ingenia Elition S with MR Elastography (MRE).
1. Model Number (REF): 781357.
2. Model Number (REF): 782106.
3. Model Number (REF): 782137.
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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-1961-2026 - Philips Ingenia Ambition X with MR Elastography (MRE).
1. Model Number (REF): 781356.
2. Model Number (REF): 782109.
3. Model Number (REF): 782138.
4. Model Number (REF): 782160.
...
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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
|