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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1150-2026 - Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CMS
Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information ...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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Z-1151-2026 - Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CNS, MFM-CNS Lite
Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applicatio...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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Z-1141-2026 - Brand Name: EDAN
Product Name: Fetal & Maternal Monitor
Model/Catalog Number: F6, F9, F6 Express, F9 Express
Product Description: The devices are bedside fetal and maternal monitors, which are used...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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 ...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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 ...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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Z-1154-2026 - Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM8, iM8A, iM8B
Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiolo...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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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...
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2
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01/22/2026
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FEI # 3009499478 Edan Diagnostics
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