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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 17 Results
510(K) Number: K213583
 
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Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.... 2 04/27/2026 FEI # 3006648320
Philips North America
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2.... 2 04/27/2026 FEI # 3006648320
Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and ... 2 01/29/2026 FEI # 3006648320
Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. 2 01/29/2026 FEI # 3006648320
Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version ... 2 01/29/2026 FEI # 3006648320
Philips North America
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 7821... 2 05/16/2025 FEI # 3016618143
Philips North America Llc
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to th... 2 06/04/2024 FEI # 3016618143
Philips North America Llc
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to... 2 06/04/2024 FEI # 3016618143
Philips North America Llc
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to th... 2 06/04/2024 FEI # 3016618143
Philips North America Llc
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 2 05/17/2024 FEI # 3016618143
Philips North America Llc
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