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Philips North America

126 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Intera 1.5T, Model No. 781195 recall (Z-0811-2024)Philips North America2024-01-25
SmartPath to dStream for 1.5T, Model No. 781260, 782112 recall (Z-0812-2024)Philips North America2024-01-25
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expa recall (Z-0731-2024)Philips North America2024-01-13
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 recall (Z-0732-2024)Philips North America2024-01-13
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable p recall (Z-0719-2024)Philips North America2024-01-12
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781 recall (Z-0715-2024)Philips North America2024-01-11
BrightView, Gamma Camera System, Product Code 882480. recall (Z-0677-2024)Philips North America2024-01-05
BrightView X, Gamma Camera, Product Code 882478 recall (Z-0678-2024)Philips North America2024-01-05
BrightView XCT, Gamma Camera, Product Code 882482 recall (Z-0679-2024)Philips North America2024-01-05
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 recall (Z-0319-2024)Philips North America2023-11-16
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 recall (Z-0306-2024)Philips North America2023-11-15
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 7821 recall (Z-2395-2023)Philips North America2023-08-11
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 recall (Z-2396-2023)Philips North America2023-08-11
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7 recall (Z-2397-2023)Philips North America2023-08-11
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 7821 recall (Z-2398-2023)Philips North America2023-08-11
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 recall (Z-2399-2023)Philips North America2023-08-11
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7 recall (Z-2400-2023)Philips North America2023-08-11
Incisive CT-Computed Tomography X-Ray System Model: 728143 recall (Z-2258-2023)Philips North America2023-07-28
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 recall (Z-2259-2023)Philips North America2023-07-28
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 recall (Z-2260-2023)Philips North America2023-07-28
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 recall (Z-2261-2023)Philips North America2023-07-28
ProxiDiagnost N90 R.1.0 recall (Z-1587-2023)Philips North America2023-05-15
CombiDiagnost R90 R.1.0 recall (Z-1588-2023)Philips North America2023-05-15
CombiDiagnost R90 R1.1 recall (Z-1589-2023)Philips North America2023-05-15
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 recall (Z-1585-2023)Philips North America2023-05-12
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 recall (Z-1586-2023)Philips North America2023-05-12
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