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RecallWatchMedical Device Safety
Class IIOngoingZ-1154-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8

Edan DiagnosticsSan Diego, CA, United StatesReported Jan 28, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No

Lot / code information

Model
iM8
UDI
code: 06944413801592 Serial/
Lot #
260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009…Show all
260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009 260645-M15C07240018 260645-M15C07240019 260645-M15C07240020 260645-M15C07240010 260645-M15C07240011 260645-M15C07240012 260645-M15C07240013 260645-M15C07240014 260645-M15C07240002 260645-M15C07240003 260645-M16200530008 260645-M16200530007 260645-M16200530006 260645-M16200530005 260645-M16200530001 260645-M16200530003 260645-M16200530002 260645-M16200530004 260605-M16304610008 260605-M16304610010 260605-M16304610007 260605-M16304610009 260605-M16304610006 260605-M16304610001 260605-M16304610004 260605-M16304610003 260605-M16304610002 260605-M16304610005 260605-K16300150005 260605-K16300150006 260605-K16300150007 260605-K16300150008 260605-K16300150009 260605-K16300150010 260605-K16300150004 260645-M16203940001 260645-M16203940003 260645-M16203940005 260645-M16203940006 260645-M16203940007 260645-M16203940008 260645-M16203940002 260605-K16300150003 260605-K16300150002 260605-K16300150001 260645-M16203940009 260645-M16203940010 260645-M16203940004 260645-M16203940012 260645-M16203940011 260605-M16313860011 260605-M16313860018 260605-M16313860017 260605-M16313860016 260605-M16313860019 260605-M16313860015 260605-M16313860014 260605-M16313860013 260605-M16313860012 260605-M16313860010 260605-M16313860005 260605-M16313860008 260605-M16313860007 260605-M16313860006 260605-M16313860020 260605-M16313860004 260605-M16313860003 260605-M16313860002 260605-M16313860001 260605-M16313860009 260605-M16314840022 260605-M16314840023 260605-M16314840024 260605-M16314840025 260605-M16314840026 260605-M16314840027 260605-M16314840030 260605-M16314840029 260605-M16314840021 260645-M16314850001 260645-M16314850002 260645-M16314850003 260645-M16314850004 260645-M16314850005 260605-M16314840028 260605-M16314840020 260605-M16314840016 260605-M16314840018 260605-M16314840001 260605-M16314840002 260605-M16314840003 260605-M16314840004 260605-M16314840005 260605-M16314840006 260605-M16314840019 260605-M16314840007 260605-M16314840009 260605-M16314840011 260605-M16314840013 260605-M16314840014 260605-M16314840015 260605-M16314840017 260605-M16314840008 260605-M16314840010 260605-M16314840012 260605-M16406990019 260605-M16406990018 260605-M16406990016 260605-M16406990013 260605-M16406990015 260605-M16406990014 260605-M16406990017 260605-M16406990020 260645-M16406980017 260645-M16406980002 260645-M16406980020 260645-M16406980019 260645-M16406980018 260605-M16406990012 260645-M16406980016 260645-M16406980015 260645-M16406980014 260645-M16406980013 260645-M16406980001 260645-M16406980012 260645-M16406980010 260645-M16406980009 260645-M16406980008 260645-M16406980007 260645-M16406980006 260645-M16406980005 260645-M16406980004 260645-M16406980003 260645-M16406980011 260605-M16406990011 260605-M16406990004 260605-M16406990009 260605-M16406990001 260605-M16406990002 260605-M16406990003 260605-M16406990005 260605-M16406990006 260605-M16406990007 260605-M16406990008 260605-M16406990010 260645-M16407130030 260645-M16407130028 260645-M16407130026 260645-M16407130025 260645-M16407130024 260645-M16407130023 260645-M16407130022 260645-M16407130021 260645-M16407130020 260645-M16407130019 260645-M16407130018 260645-M16407130027 260645-M16407130017 260645-M16407130016 260645-M16407130029 260645-M16407130014 260605-M16407120010 260605-M16407120009 260605-M16407120008 260605-M16407120007 260605-M16407120006 260605-M16407120005 260605-M16407120004 260605-M16407120003 260605-M16407120002 260645-M16407130015 260605-M16407120011 260605-M16407120012 260605-M16407120001 260605-M16407120014 260605-M16407120013 260645-M16407130013 260645-M16407130012 260645-M16407130011 260645-M16407130010 260645-M16407130009 260645-M16407130007 260645-M16407130006 260645-M16407130005 260645-M16407130004 260645-M16407130008 260645-M16407130003 260645-M16407130002 260645-M16407130001 260605-M16407120020 260605-M16407120019 260605-M16407120018 260605-M16407120017 260605-M16407120016 260605-M16407120015 260645-M16810740010 260645-M16810740009 260645-M16810740008 260645-M16810740007 260645-M16810740006 260645-M16810740005 260645-M16810740004 260645-M16810740001 260645-M16810740002 260645-M16810740003 260645-M16B08640010 260645-M16B08640009 260645-M16B08640008 260645-M16B08640007 260645-M16B08640006 260645-M16B08640005 260645-M16B08640004 260645-M16B08640003 260645-M16B08640002 260645-M16B08640001 260605-M16B08630005 260605-M16B08630004 260605-M16B08630003 260605-M16B08630002 260605-M16B08630001 260605-M16C02510002 260605-M16C02510001 260605-M16B08650001 260605-M16B08650002 260605-M16B08650003 260605-M16B08650004 260605-M16B08650005 260645-M16B08660001 260645-M16B08660002 260645-M16B08660003 260645-M16B08660004 260645-M16B08660005 260645-M16B08660007 260645-M16B08660008 260645-M16B08660009 260645-M16B08660010 260645-M16B08660006 260645-M17201890014 260605-M17201880005 260605-M17201880006 260605-M17201880009 260605-M17201880007 260605-M17201880014 260645-M17201890001 260605-M17201880002 260605-M17201880008 260645-M17201890003 260605-M17201880013 260605-M17201880010 260645-M17201890005 260605-M17201880012 260605-M17201880015 260645-M17201890002 260645-M17201890004 260645-M17201890013 260605-M17201880001 260605-M17201880011 260645-M17201890007 260605-M17201880003 260605-M17201880004 260645-M17201890010 260645-M17201890012 260645-M17201890006 260645-M17201890009 260645-M17201890011 260645-M17201890015 260645-M17201890008 260605-M17302780001 260605-M17302780010 260605-M17302780007 260605-M17302780003 260605-M17302780004 260605-M17302780008 260605-M17302780005 260605-M17302780002 260605-M17302780006 260605-M17302780009 260605-M17304380015 260605-M17304380008 260605-M17304380014 260605-M17304380007 260605-M17304380013 260605-M17304380010 260605-M17304380003 260605-M17304380001 260605-M17304380011 260605-M17304380002 260605-M17304380004 260605-M17304380009 260605-M17304380006 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Additional code information

006 260605-M20808580012 260605-M20808580036 260605-M20808580050 260605-M20808580052 260605-M20808580054 260605-M20808580011 260605-M20808580015 260605-M20808580017 260605-M20808580020 260605-M20808580023 260605-M20808580029 260605-M20808580053 260605-M20808580059 260605-M20808580001 260605-M20808580005 360001-M20A11130006 360001-M20A11130003 360001-M20A11130002 360001-M20A11130027 360001-M20A11130025 360001-M20A11130015 360001-M20A13140030 360001-M20A13140022 360001-M20A13140011 360001-M20A11130016 360001-M20A11130012 360001-M20A11130007 360001-M20A11130005 360001-M20A13140021 360001-M20A13140020 360001-M20A13140014 360001-M20A13140012 360001-M20A13140002 360001-M20A11130030 360001-M20A11130021 360001-M20A11130017 360001-M20A13140025 360001-M20A11130009 360001-M20A11130028 360001-M20A11130011 360001-M20A11130018 360001-M20A11130024 360001-M20A13140003 360001-M20A13140007 360001-M20A13140008 360001-M20A13140009 360001-M20A13140017 360001-M20A11130004 360001-M20A11130008 360001-M20A11130010 360001-M20A11130013 360001-M20A11130020 360001-M20A11130022 360001-M20A11130023 360001-M20A11130026 360001-M20A13140004 360001-M20A13140026 360001-M20A13140027 360001-M20A13140028 360001-M20A13140029 360001-M20A13140005 360001-M20A13140013 360001-M20A13140015 360001-M20A13140024 360001-M20A11130001 360001-M20A11130014 360001-M20A11130029 360001-M20A11130019 360001-M20A13140019 360001-M20A13140023 360001-M20A13140018 360001-M20A13140010 360001-M20A13140006 360001-M20A13140001 360001-M20A13140016 260605-M20C13200006 260605-M20C13200024 260605-M20C16040006 260605-M20C13200028 260605-M20C13200003 260605-M20C13200009 260605-M20C13200015 260605-M20C13200025 260605-M20C16040001 260605-M20C16040002 260605-M20C16040007 260605-M20C16040009 260605-M20C13200004 260605-M20C13200008 260605-M20C16040010 260605-M20C13200026 260605-M20C16040014 260605-M20C16040020 260605-M20C13200012 260605-M20C13200017 260605-M20C13200022 260605-M20C13200027 260605-M20C16040011 260605-M20C16040017 260605-M20C16040019 260605-M20C16040008 260605-M20C16040004 260605-M20C13200007 260605-M20C16040013 260605-M20C13200018 260605-M20C13200021 260605-M20C13200030 260605-M20C16040018 260605-M20C13200005 260605-M20C13200019 260605-M20C13200029 260605-M20C13200002 260605-M20C13200014 260605-M20C16040015 260605-M20C13200010 260605-M20C13200013 260605-M20C13200016 260605-M20C13200020 260605-M20C13200023 260605-M20C16040003 260605-M20C16040005 260605-M20C16040012 260605-M20C16040016 260605-M20C13200001 260605-M20C13200011 260605-M20C13190026 260605-M20C13190015 260605-M20C13190006 260605-M20C13190002 260605-M20C13190001 260605-M20C13190070 260605-M20C13190065 260605-M20C13190053 260605-M20C13190047 260605-M20C13190043 260605-M20C13190029 260605-M20C13190017 260605-M20C13190013 260605-M20C13190009 260605-M20C13190067 260605-M20C13190063 260605-M20C13190056 260605-M20C13190052 260605-M20C13190051 260605-M20C13190050 260605-M20C13190046 260605-M20C13190042 260605-M20C13190020 260605-M20C13190021 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360001-M21C04420 …

What the firm is doing

On 10/24/2025, the firm emailed notifying customers of a product recall. On 11/06/2025, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration. -First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and Second issue involves an inappropriate publicly IP address that was used as the factory default configuration. Customer are instructed to: 1. Immediately examine their inventory and quarantine product subject to correction. 2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION. 3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and Corrigenda of User Manual into its package before distribution. 4. For affected product that has been distributed or is in use: (1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual. (2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration. 5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email. For questions - Contact: EDAN Instruments, Inc. Monday to Friday 09:00-17:00 (UTC+8) Tel:+86-0755-26898326 EDAN Diagnostics, Inc. Monday to Friday 09:00-17:00 (PST) Tel: 1-(858)-750-3066

DistributionShow details

Worldwide - 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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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