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U.S. Department of Health and Human Services

Class 2 Device Recall EDAN

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 Class 2 Device Recall EDANsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedJanuary 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1146-2026
Recall Event ID 97879
510(K)NumberK160981 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductBrand 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 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 V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
Code Information EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001 260342-M16506570001 260342-M15A03180001 002338-K22100150003 002338-K22100150004 002338-K22100150002 002338-K22100150001 261241-M22701020001 002338-M25705810020 002338-M25705810021 002338-M25705810011 002338-M25705810003 002338-M25705810013 002338-M25705810029 002338-M25705810033 002338-M25705810001 002338-M25705810010 002338-M25705810009 002338-M25705810004 002338-M25705810012 002338-M25705810018 002338-M25705810032 002338-M25705810017 002338-M25705810019 002338-M25705810024 002338-M25705810030 002338-M25705810031 002338-M25705810025 002338-M25705810016 002338-M25705810008 002338-M25705810006 002338-M25705810002 002338-M25705810028 002338-M25705810027 002338-M25705810022 002338-M25705810026 002338-M25705810023 002338-M25705810015 002338-M25705810014 002338-M25705810005 002338-M25705810007 002338-M25908680004 002338-M25908680003 002338-M25908680002 002338-M25908680001 EDAN Model: elite V5 UDI-DI code: 06944413802155 Serial/Lot Numbers: 260586-M17211520002 260586-M17211520006 260586-M17211520004 260586-M17211520008 260586-M17211520001 260586-M17211520009 260586-M17211520007 260586-M17211520003 260586-M17211520010 260586-M17211520005 260588-M17902120009 260588-M17902120002 260588-M17902120008 260588-M17902120001 260588-M17902120003 260588-M17902120006 260588-M17902120007 260588-M17902120004 260588-M17902120005 260588-M17902120010 260586-M19413090016 260586-M19413090007 260586-M19413090017 260586-M19413090006 260586-M19413090010 260586-M19413090014 260586-M19413090011 260586-M19413090008 260586-M19413090004 260586-M19413090019 260586-M19413090012 260586-M19413090003 260586-M19413090013 260586-M19413090009 260586-M19413090005 260586-M19413090002 260586-M19413090018 260586-M19413090001 260586-M19413090020 260586-M19413090015 260586-M19507110023 260586-M19507110013 260586-M19507110005 260586-M19507110009 260586-M19507110004 260586-M19507110019 260586-M19507110018 260586-M19507110024 260586-M19507110003 260586-M19507110008 260586-M19507110020 260586-M19507110014 260586-M19507110001 260586-M19507110002 260586-M19507110016 260586-M19507110010 260586-M19507110011 260586-M19507110012 260586-M19507110015 260586-M19507110021 260586-M19507110022 260586-M19507110007 260586-M19507110006 260586-M19507110025 260586-M19507110017 260586-M19604520007 260586-M19604520005 260586-M19604520006 260586-M19604520008 260586-M19604520001 260586-M19604520011 260586-M19604520010 260586-M19604520003 260586-M19604520009 260586-M19604520002 260586-M19604520004 260586-M19701080013 260586-M19702060010 260586-M19702060002 260586-M19702060003 260586-M19702060006 260586-M19702060013 260586-M19702060014 260586-M19701080004 260586-M19701080010 260586-M19701080011 260586-M19701080018 260586-M19701080003 260586-M19702060004 260586-M19701080007 260586-M19702060007 260586-M19701080008 260586-M19701080005 260586-M19701080009 260586-M19702060005 260586-M19702060015 260586-M19701080002 260586-M19701080019 260586-M19701080012 260586-M19702060001 260586-M19702060011 260586-M19701080020 260586-M19702060008 260586-M19701080014 260586-M19701080016 260586-M19702060009 260586-M19702060012 260586-M19701080001 260586-M19701080015 260586-M19701080006 260586-M19701080017 260586-M19805320026 260586-M19805320038 260586-M19805320024 260586-M19805320014 260586-M19805320001 260586-M19805320055 260586-M19805320046 260586-M19805320045 260586-M19805320054 260586-M19805320015 260586-M19805320023 260586-M19805320020 260586-M19805320016 260586-M19805320004 260586-M19805320008 260586-M19805320053 260586-M19805320050 260586-M19805320002 260586-M19805320048 260586-M19805320025 260586-M19805320009 260586-M19805320011 260586-M19805320027 260586-M19805320043 260586-M19805320052 260586-M19805320051 260586-M19805320041 260586-M19805320031 260586-M19805320029 260586-M19805320022 260586-M19805320021 260586-M19805320019 260586-M19805320012 260586-M19805320049 260586-M19805320042 260586-M19805320039 260586-M19805320032 260586-M19805320006 260586-M19805320005 260586-M19805320003 260586-M19805320044 260586-M19805320034 260586-M19805320017 260586-M19805320040 260586-M19805320035 260586-M19805320036 260586-M19805320033 260586-M19805320030 260586-M19805320028 260586-M19805320018 260586-M19805320013 260586-M19805320007 260586-M19805320047 260586-M19805320010 260586-M19805320037 260586-M20B07060008 260586-M20B07060005 260586-M20B07060007 260586-M20B07060010 260586-M20B07060001 260586-M20B07060006 260586-M20B07060011 260586-M20B07060003 260586-M20B07060009 260586-M20B07060004 260586-M20B07060012 260586-M20B07060002 260586-M20B10740014 260586-M20B10740008 260586-M20B10740015 260586-M20B10740005 260586-M20B10740004 260586-M20B10740007 260586-M20B10740012 260586-M20B10740001 260586-M20B10740003 260586-M20B10740013 260586-M20B10740009 260586-M20B10740011 260586-M20B10740006 260586-M20B10740010 260586-M20B10740002 260586-M20B17820010 260586-M20B17820001 260586-M20B17820003 260586-M20B17820008 260586-M20B17820005 260586-M20B17820004 260586-M20B17820002 260586-M20B17820007 260586-M20B17820009 260586-M20B17820006 260586-M21C04150002 260586-M21C04150004 260586-M21C04150005 260586-M21C04150009 260586-M21C04150008 260586-M21C04150010 260586-M21C04150006 260586-M21C04150003 260586-M21C04150001 260586-M21C04150007 260586-M22102050013 260586-M22102050004 260586-M22102050008 260586-M22102050006 260586-M22102050001 260586-M22102050015 260586-M22102050005 260586-M22102050014 260586-M22102050007 260586-M22102050002 260586-M22102050012 260586-M22102050009 260586-M22102050010 260586-M22102050003 260586-M22102050011 260586-M22804770008 260586-M22804770011 260586-M22804770010 260586-M22804770005 260586-M22804770004 260586-M22804770012 260586-M22804770002 260586-M22804770001 260586-M22804770009 260586-M22804770003 260586-M22804770006 260586-M22804770007 260586-M23515110001 260586-M23515110010 260586-M23515110009 260586-M23515110003 260586-M23515110008 260586-M23515110007 260586-M23515110002 260586-M23515110006 260586-M23515110004 260586-M23515110005 260586-M24119070001 260586-M24119070003 260586-M24119070004 260586-M24119070002 260586-M24408410002 260586-M24408410001 260586-M24610240005 260586-M24610240002 260586-M24610240004 260586-M24610240001 260586-M24610240003 260586-M21308230001 260586-M21816190003 260586-M21816190001 260586-M21816190002 260586-M21816190004 260586-M21816190005 260586-M21816190006 260586-M21C13880002 260586-M21C13880001 260586-M22410650002 260586-M22410650001 260586-M22A01240001 260586-M22A01240002 EDAN Model: elite V6 UDI-DI code: 06944413802162 Serial/Lot Numbers: 260598-M17409030001 260597-M18402870001 260597-M23613650001 260598-M17207680001 260597-M17211510002 260597-M17211510001 260597-M20B20220001 260597-M23515100001 260597-M24803380006 260597-M24803380005 260597-M24803380002 260597-M24803380001 260597-M24803380004 260597-M24803380003 260597-M21816200001 260597-M25315990001
FEI Number 3009499478
Recalling Firm/
Manufacturer		 Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
For Additional Information ContactChao Lin
858-7503066
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce342
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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