Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NamePatient
- Monitor Model/Catalog Number
iX10iX12
- iX15 Product DescriptionThe iX series Patient Monitors including iX10, iX12, iX15 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate
- ComponentNo
- Lot codes and dates
- EDAN ModeliX10
- UDI-DI code06944413815889
- Serial/Lot Numbers
144 of 144 codes
262541-M24816120001262541-M24A09820001262541-M24B06240003262541-M24B06240002262541-M24B06240001262541-M25110410016262541-M25110420014262541-M25110420008262541-M25110420009262541-M25110420024262541-M25110420023262541-M25110420025262541-M25110420018262541-M25110410001262541-M25110410009262541-M25110410003262541-M25110410004262541-M25110410011262541-M25110410015262541-M25110410020262541-M25110410002262541-M25110410012262541-M25110410005262541-M25110410013262541-M25110410014262541-M25110410007262541-M25110410008262541-M25110410017262541-M25110410018262541-M25110410019262541-M25110410010262541-M25110420011262541-M25110410006262541-M25110420007262541-M25110420020262541-M25110420013262541-M25110420001262541-M25110420019262541-M25110420022262541-M25110420003262541-M25110420010262541-M25110420015262541-M25110420004262541-M25110420016262541-M25110420012262541-M25110420005262541-M25110420017262541-M25110420021262541-M25110420006262541-M25110420002269944-M25514090006269944-M25514090002269944-M25514090004269944-M25514090008269944-M25514090007269944-M25514090001269965-M25510270004269965-M25510270003269965-M25510270001269944-M25514090009
- EDAN ModeliX12
- UDI-DI code06944413815896
- Serial/Lot Numbers
202 of 202 codes
262542-M23808800001262542-M24B06270001262542-M24B06280001262542-M24B06250001262542-M24B06280002262542-M24B06270002262542-M24B06260001262542-M24B06250002262542-M25110440008262542-M25110430024262542-M25110430020262542-M25110430009262542-M25110430006262542-M25110430001262542-M25110440016262542-M25110440010262542-M25110440005262542-M25110440003262542-M25110440001262542-M25110430021262542-M25110430013262542-M25110430007262542-M25110440011262542-M25110430003262542-M25110440017262542-M25110440015262542-M25110440020262542-M25110430005262542-M25110430010262542-M25110430012262542-M25110430014262542-M25110430018262542-M25110440007262542-M25110430011262542-M25110430016262542-M25110430017262542-M25110440013262542-M25110440018262542-M25110430019262542-M25110440019262542-M25110440014262542-M25110440006262542-M25110430023262542-M25110430015262542-M25110430002262542-M25110430022262542-M25110440012262542-M25110430004262542-M25110440009262542-M25110440004262542-M25110440002262542-M25110430025262542-M25110430008269943-M25514100009269943-M25514100033269963-M25510300013269943-M25514100030269943-M25514100031269963-M25510300011269963-M25510300026
- EDAN ModeliX15
- UDI-DI code06944413815902
- Serial/Lot Numbers
262543-M24B06290002262543-M24B06290001262543-M25110450003262543-M25110450002262543-M25110450001262543-M25110450004262543-M25110450005262543-M25303610001269961-M25510320004269961-M25510320002269961-M25510320010269942-M25514110006269961-M25510320008269961-M25510320005269961-M25510320011269942-M25514110001269942-M25514110003269961-M25510320012269961-M25510320013269942-M25514110010269961-M25510320009269961-M25510320006269961-M25510320001269942-M25514110007269942-M25514110008269961-M25510320015269961-M25510320003269942-M25514110005269961-M25510320014269961-M25510320007269942-M25514110004269942-M25514110002269942-M25514110009
- Amount recalled
- 379
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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