What should I do if I have an affected iM20 Patient Monitor?

Stop using the device immediately and contact Edan Diagnostics for specific return instructions. Follow any additional guidance from your healthcare provider.

How do I know if my iM20 Patient Monitor is affected?

Check the model number and serial numbers against the list provided in the recall announcement. If in doubt, consult your healthcare provider.

Are there any reported injuries from the iM20 recall?

As of now, there have been no reported injuries related to the iM20 Patient Monitor's cybersecurity issues.

What kind of cybersecurity issues are involved in this recall?

The recall involves vulnerabilities that could potentially compromise patient data and device functionality. Specific details were outlined in the FDA's communication.

How long will it take to process my refund or replacement?

Typically, refunds or replacements can take 4-6 weeks to process, depending on the manufacturer's response time.

Can I still use the iM20 Patient Monitor while waiting for a replacement?

No, you should stop using the iM20 Patient Monitor immediately due to the identified cybersecurity risks.

Where can I find more information about the recall?

You can find detailed recall information on the FDA's website, or you can contact Edan Diagnostics directly.

Will I receive a notification about the recall?

Yes, affected users should have received a notification letter regarding the recall from the manufacturer.

What are my rights if I purchased this product?

You are entitled to a full refund regardless of whether you have a receipt. Contact the retailer or Edan Diagnostics for assistance.

What other patient monitors are safe to use?

Consider using advanced patient monitoring systems or wireless monitors that have not been recalled and meet safety standards.

HIGHOctober 24, 2025

EDAN Recalls iM20 Patient Monitor Over Cybersecurity Risk

EDAN recalled 377 iM20 Patient Monitors on October 24, 2025, due to cybersecurity issues. The recall affects devices distributed nationwide in the U.S. and Mexico. Healthcare providers must stop using this device immediately.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: Edan Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

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Product Details

The iM20 Patient Monitor can continuously monitor multiple physiological parameters such as ECG, respiration, and blood pressure. These devices were distributed across various states in the U.S. and in Mexico.

The Hazard

The recall was prompted by an FDA letter regarding potential cybersecurity issues. These vulnerabilities could compromise patient data and the operation of the device.

Reported Incidents

There have been no reported injuries or incidents related to this recall at this time. The primary concern is the potential risk from cybersecurity vulnerabilities.

What to Do

Stop using the iM20 Patient Monitor immediately. Contact Edan Diagnostics or your healthcare provider for further instructions on the return process.

Contact Information

For more information, contact Edan Diagnostics at their customer service number or visit their website. Detailed recall information is also available on the FDA website.

Key Facts

377 units recalled
Models affected: iM20
Cybersecurity vulnerabilities identified
Stop using device immediately
Contact Edan Diagnostics for instructions

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypePatient Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

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-K21800220001 260374-M21A04520003 260374-M21A04520002 260374-M21A04520001 260374-M22105780003 260374-M22105780001 260374-M22105780002 260374-M22301830005 260374-M22301830008 260374-M22301830002 260374-M22301830004 260374-M22301830001 260374-M22301830007 260374-M22301830009 260374-M22301830003 260374-M22301830006 260374-M22301830010 260374-M22405470001 260374-M22405470004 260374-M22405470002 260374-M22405470003 260374-M22405470005 260374-M22507870001 260374-M22511350001 260374-M22511350002 260374-M22511350004 260374-M22511350003 260374-M22511350005 260374-M22800760001 260374-M22812970001 260374-M22B02100004 260374-M22B02110003 260374-M22B02100005 260374-M22B02100002 260374-M22B02100001 260374-M22B02110001 260374-M22B02110002 260374-M22B02100003 260374-M22C07450001 260374-M22C07450003 260374-M22C07450002 260374-M22C07450004 260374-M22C07450009 260374-M22C07450006 260374-M22C07450005 260374-M22C07450010 260374-M22C07450007 260374-M22C07450008 260374-M23302060001 260374-M23227000002 260374-M23227000001 260374-M23713030001 260374-M23A11780001 260374-M23A11780002 260374-M23A11780004 260374-M23A11780003 260374-M23A11780005 260374-M23C18470001 260374-M23C15730002 260374-M23C15730001 260374-M24412120003 260374-M24412120002 260374-M24412120004 260374-M24412120005 260374-M24412120001 260374-M24607940001 260374-M24618190001 260374-M24816400002 260374-M24816400001 260374-M24816400005 260374-M24816400004 260374-M24816400003 260500-M17207700001 260374-M17211490003 260374-M17211490002 260374-M17211490004 260374-M17211490001 260374-M17211490005 260374-M18112460002 260374-M18112460001 260374-M18414750001 260374-M18414750002 260374-M19314330002 260374-M19314330001 260374-M19413110001 260374-M19507180001 260374-M19507180002 260374-M19908180003 260374-M19908180001 260374-M19908180004 260374-M19908180002 260374-M19B01600002 260374-M19B01600001 260374-M19B01600003 260374-M20202590002 260374-M20202590003 260374-M20202590001 260374-M20202590004 260374-M20202590005 260374-M20502980002 260374-M20502980004 260374-M20502980006 260374-M20502980007 260374-M20502980001 260374-M20502980005 260374-M20502980008 260374-M20502980003 260374-M20914770003 260374-M20914770001 260374-M20914770002 260374-M20918140001 260374-M20918140006 260374-M20918140003 260374-M20918140004 260374-M20918140002 260374-M20918140005 260374-M20B20310026 260374-M20B20310014 260374-M20B20310099 260374-M20B20310089 260374-M20B20310080 260374-M20B20310068 260374-M20B20310066 260374-M20B20310062 260374-M20B20310061 260374-M20B20310059 260374-M20B20310015 260374-M20B20310094 260374-M20B20310081 260374-M20B20310050 260374-M20B20310049 260374-M20B20310054 260374-M20B20310060 260374-M20B20310085 260374-M20B20310095 260374-M20B20310003 260374-M20B20310005 260374-M20B20310007 260374-M20B20310017 260374-M20B20310020 260374-M20B20310029 260374-M20B20310030 260374-M20B20310039 260374-M20B20310040 260374-M20B20310013 260374-M20B20310044 260374-M20B20310034 260374-M20B20310088 260374-M20B20310019 260374-M20B20310074 260374-M20B20310087 260374-M20B20310093 260374-M20B20310097 260374-M20B20310001 260374-M20B20310002 260374-M20B20310057 260374-M20B20310006 260374-M20B20310011 260374-M20B20310012 260374-M20B20310016 260374-M20B20310018 260374-M20B20310043 260374-M20B20310047 260374-M20B20310008 260374-M20B20310073 260374-M20B20310053 260374-M20B20310037 260374-M20B20310042 260374-M20B20310046 260374-M20B20310055 260374-M20B20310064 260374-M20B20310071 260374-M20B20310072 260374-M20B20310024 260374-M20B20310076 260374-M20B20310004 260374-M20B20310023 260374-M20B20310025 260374-M20B20310027 260374-M20B20310033 260374-M20B20310035 260374-M20B20310078 260374-M20B20310075 260374-M20B20310045 260374-M20B20310090 260374-M20B20310048 260374-M20B20310051 260374-M20B20310052 260374-M20B20310056 260374-M20B20310058 260374-M20B20310069 260374-M20B20310041 260374-M20B20310079 260374-M20B20310086 260374-M20B20310091 260374-M20B20310092 260374-M20B20310096 260374-M20B20310098 260374-M20B20310077 260374-M20B20310082 260374-M20B20310038 260374-M20B20310070 260374-M20B20310084 260374-M20B20310063 260374-M20B20310065 260374-M20B20310067 260374-M20B20310009 260374-M20B20310010 260374-M20B20310100 260374-M20B20310021 260374-M20B20310083 260374-M20B20310022 260374-M20B20310028 260374-M20B20310031 260374-M20B20310032 260374-M20B20310036 260374-M20C08590002 260374-M20C08590010 260374-M20C08590004 260374-M20C08590003 260374-M20C08590008 260374-M20C08590007 260374-M20C08590009 260374-M20C08590005 260374-M20C08590001 260374-M20C08590006 260374-M21113140002 260374-M21113140004 260374-M21113140010 260374-M21113140005 260374-M21113140003 260374-M21113140009 260374-M21113140006 260374-M21113140008 260374-M21113140007 260374-M21113140001 260374-M23802320001 260374-M23802320003 260374-M23802320002 260374-M23B14130013 260374-M23B14130008 260374-M23B14130027 260374-M23B14130025 260374-M23B14130028 260374-M23B14130020 260374-M23B14130021 260374-M23B14130011 260374-M23B14130003 260374-M23B14130022 260374-M23B14130019 260374-M23B14130012 260374-M23B14130001 260374-M23B14130014 260374-M23B14130010 260374-M23B14130009 260374-M23B14130002 260374-M23B14130018 260374-M23B14130007 260374-M23B14130005 260374-M23B14130024 260374-M23B14130006 260374-M23B14130026 260374-M23B14130016 260374-M23B14130004 260374-M23B14130015 260374-M23B14130017 260374-M23B14130023 260374-M23C11330001 260374-M23C11330009 260374-M23C11330007 260374-M23C11330008 260374-M23C11330005 260374-M23C11330004 260374-M23C11330003 260374-M23C11330010 260374-M23C11330006 260374-M23C11330002 260374-M23C18730005 260374-M23C18730002 260374-M23C18730001 260374-M23C18730004 260374-M23C18730003 260374-M24118900004 260374-M24118900005 260374-M24118900003 260374-M24118900001 260374-M24118900002 260374-M24803340005 260374-M24803340002 260374-M24803340006 260374-M24803340003 260374-M24803340001 260374-M24803340004 262244-M22701050001 260374-M25216280003 260374-M25216280002 260374-M25216280001 260374-M25312790001 260374-M25309570001 260374-M25312790002 260374-M25520360002 260374-M25520360004 260374-M25520360003 260374-M25520360005 260374-M25520360001 260374-M25709700004 260374-M25709700005 260374-M25709700001 260374-M25709700003 260374-M25709700002 260374-M25906630001 260374-M25904250004 260374-M25904250008 260374-M25904250009 260374-M25904250002 260374-M25904250005 260374-M25901780001 260374-M25901780006 260374-M25901780007 260374-M25901780004 260374-M25901780008 260374-M25904250001 260374-M25901780002 260374-M25904250003 260374-M25904250010 260374-M25901780005 260374-M25904250006 260374-M25901780003 260374-M25904250011 260374-M25904250012 260374-M25904250007

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

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