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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-1152-2026 - Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3B
Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vita...
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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-1153-2026 - Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3A
Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The mon...
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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-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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