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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-1836-2024 - Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 781296
(2) 781343
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2
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05/17/2024
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Philips North America Llc
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Z-1865-2024 - Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 782127
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2
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05/17/2024
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Philips North America Llc
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Z-1838-2024 - Achieva 1.5T Initial system
Model Number (REF): 781178
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2
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05/17/2024
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Philips North America Llc
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Z-1839-2024 - Achieva 3.0T
Model Number (REF):
(1) 781345;
(2) 781344;
(3) 781278;
(4) 781277;
(5) 781177
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2
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05/17/2024
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Philips North America Llc
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Z-1840-2024 - Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 781477
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2
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05/17/2024
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Philips North America Llc
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Z-1841-2024 - Achieva 3.0T TX for PET
Model Number (REF): 781479
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2
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05/17/2024
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Philips North America Llc
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Z-1842-2024 - AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 781253
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2
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05/17/2024
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Philips North America Llc
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Z-1843-2024 - Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 782116;
(2) 782148
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2
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05/17/2024
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Philips North America Llc
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Z-1844-2024 - Evolution upgrade 3.0T
Model Number (REF):
(1)782117;
(2) 782143
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2
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05/17/2024
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Philips North America Llc
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Z-1845-2024 - Ingenia 1.5T
Model Number (REF):
(1) 782140;
(2) 782115;
(3) 782101;
(4) 781396;
(5) 781341;
(6) 781315
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2
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05/17/2024
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Philips North America Llc
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