Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series…
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
iM8iM8A
- iM8B Product DescriptioniM8 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
- ComponentNo
- Lot codes and dates
- EDAN ModeliM8
- UDI-DI code06944413801592
- Serial/Lot Numbers
1,627 of 1,627 codes
260645-M15C07240016260645-M15C07240001260645-M15C07240004260645-M15C07240005260645-M15C07240017260645-M15C07240006260645-M15C07240007260645-M15C07240008260645-M15C07240015260645-M15C07240009260645-M15C07240018260645-M15C07240019260645-M15C07240020260645-M15C07240010260645-M15C07240011260645-M15C07240012260645-M15C07240013260645-M15C07240014260645-M15C07240002260645-M15C07240003260645-M16200530008260645-M16200530007260645-M16200530006260645-M16200530005260645-M16200530001260645-M16200530003260645-M16200530002260645-M16200530004260605-M16304610008260605-M16304610010260605-M16304610007260605-M16304610009260605-M16304610006260605-M16304610001260605-M16304610004260605-M16304610003260605-M16304610002260605-M16304610005260605-K16300150005260605-K16300150006260605-K16300150007260605-K16300150008260605-K16300150009260605-K16300150010260605-K16300150004260645-M16203940001260645-M16203940003260645-M16203940005260645-M16203940006260645-M16203940007260645-M16203940008260645-M16203940002260605-K16300150003260605-K16300150002260605-K16300150001260645-M16203940009260645-M16203940010260645-M16203940004260645-M16203940012260645-M16203940011
- Amount recalled
- 3141
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.
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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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