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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
Related Medical Device Recalls
 
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Z-1140-2026 - Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological param... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1155-2026 - Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyz... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1142-2026 - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The moni... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1143-2026 - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, includi... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1144-2026 - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are int... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1145-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-t... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1146-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can p... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1147-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring ... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1148-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous ... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1149-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
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