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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 16 Results
510(K) Number: K180015
 
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Philips Incisive CT 2 01/08/2026 FEI # 3009529630
Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT; Software Version Number: 4.5, 5.0, 5.1; 2 12/03/2025 FEI # 3016618143
Philips North America Llc
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1... 2 10/27/2025 FEI # 3017726341
PHILIPS MEDICAL SYSTEMS
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.... 2 10/27/2025 FEI # 3017726341
PHILIPS MEDICAL SYSTEMS
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; 2 10/27/2025 FEI # 3017726341
PHILIPS MEDICAL SYSTEMS
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the bod... 2 05/20/2024 FEI # 3016618143
Philips North America Llc
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to... 2 04/09/2024 FEI # 3006648320
Philips North America
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 2 07/28/2023 FEI # 3006648320
Philips North America
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 2 07/28/2023 FEI # 3006648320
Philips North America
Incisive CT-Computed Tomography X-Ray System Model: 728143 2 07/28/2023 FEI # 3006648320
Philips North America
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