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Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
Device Recall Signify Mono (Whole Blood, Serum, Plasma)
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Stanbio Rely Mono Rapid Test
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Proadvantage Mono Rapid Test Cassette
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Henry Schein One Step Mono Rapid Test Device
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Clearview MONO (Whole Blood, Serum, Plasma),
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Cardinal Health Mono Rapid Test
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma)
Immunology and Microbiology Devices
Alere San Diego, Inc.
2
United States
Device Recall Alere Cholestech LDX Multianalyte Controls
Clinical Chemistry and Clinical Toxicology Devices
Alere San Diego, Inc.
1
United States
Device Recall INRatio 2 Monitors
Hematology and Pathology Devices
Alere San Diego, Inc.
2
United States
Device Recall INRatio Monitors
Hematology and Pathology Devices
Alere San Diego, Inc.
2
United States
Device Recall Alere INRatio PT/INR Test Strips, Alere INRatio
Hematology and Pathology Devices
Alere San Diego, Inc.
2
United States
Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
Orthopedic Devices
Orthosensor, Inc.
2
United States
Philips Brilliance 64/Ingenuity FamilyCT Scanners
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Brilliance 64/Ingenuity FamilyCT Scanners
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Brilliance 64/Ingenuity FamilyCT Scanners
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Brilliance 64/Ingenuit Family CT Scanners
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
IQon Spectral CT Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Ingenuity Core Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Ingenuity Core 128 Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Ingenuity CT Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Brilliance ICT SP Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Brilliance iCT Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Healthcare Ingenuity CT Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Healthcare Ingenuity Core 128 Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
Philips Healthcare Ingenuity Core Computed Tomography Xray system
Radiology Devices
Philips Medical Systems (Cleveland) Inc
2
United States
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