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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 12 Results
510(K) Number: K213516
 
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Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13; 2 09/25/2026 FEI # 3006648320
Philips North America
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R... 2 09/25/2026 FEI # 3006648320
Philips North America
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); 2 09/18/2026 FEI # 3016618143
Philips North America Llc
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. 2 04/27/2026 FEI # 3006648320
Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mode... 2 04/27/2026 FEI # 3006648320
Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.... 2 01/29/2026 FEI # 3006648320
Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. 2 01/29/2026 FEI # 3006648320
Philips North America
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; 2 07/30/2025 FEI # 3006648320
Philips North America
Product Name: Upgrade to MR 7700; Model Number: 782130; 2 05/16/2025 FEI # 3016618143
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; 2 05/16/2025 FEI # 3016618143
Philips North America Llc
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