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 of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
USBrand 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 of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
Recalling Firm: Edan Diagnostics
Motivo del Retiro / Peligro
TranslatedAs a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Descripción del Producto e Identificación
TranslatedBrand 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 of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
Productos Afectados
TranslatedBrand 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 of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 97879 |
| Address 1 | 9833 Pacific Heights Blvd |
| Code info | EDAN Model: iM20 UDI-DI code: 06944413802179 Serial/Lot Numbers: 260502-M17A03230001 260374-M18401280001 260374-M18401280002 260374-M18407120001 260374-M18407120002 260374-M18613240001 260374-M18613240002 260374-M18A08010001 260374-M20506470001 260374-M20506470003 260374-M20506470005 260374-M20506470002 260374-M20506470004 260374-M18402820001 260374-M20B06690002 260374-M20B06690003 260374-M20B06690001 260374-M20C13130002 260374-M20C13130004 260374-M20C13130001 260374-M20C13130003 260374-M20C13130005 260374-M21108520006 260374-M21108520015 260374-M21108520009 260374-M21108520004 260374-M21108520001 260374-M21108520014 260374-M21108520011 260374-M21108520007 260374-M21108520002 260374-M21108520005 260374-M21108520003 260374-M21108520010 260374-M21108520012 260374-M21108520013 260374-M21108520008 260374-M21608850002 260374-M21616970003 260374-M21608850001 260374-M21608850005 260374-M21608850004 260374-M21616970002 260374-M21608850003 260374-M21616970001 260374-K21800220002 260374-K2180022... [TRUNCATED] |
| Postal code | 92121-4707 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 377 |
| Reason for recall | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251024 |
| Initial firm notification | Letter |
| Center classification date | 20260122 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monit...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableEdan Diagnostics
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
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🚨 SAFETY ALERT: Edan Diagnostics - 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 of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No Check if your household is affected: https://therecallfile.com/es/recalls/brand-name-edan-product-name-patient-monitor-model-catalog-number-im20/FDA-Z-1147-2026
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