Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series ... — FDA record Z-1154-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Edan Diagnostics
- Quantity
- 3141
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1154-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | EDAN Model: iM8 UDI-DI code: 06944413801592 Serial/Lot Numbers: 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 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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 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260645-M17807720003 260605-M17807710015 260605-M17807710016 260605-M17807710010 260605-M17807710003 260605-M17807710007 260605-M17807710017 260605-M17807710018 260605-M17807710014 260605-M17807710009 260645-M17807720002 260645-M17807720001 260605-M17807710019 260605-M17807710008 260605-M17807710004 260605-M17807710022 260605-M17807710012 260605-M17807710002 260645-M17807720004 260605-M17807710024 260605-M17807710021 260605-M17811100004 260605-M17811100017 260645-M17811110010 260605-M17811100002 260605-M17811100001 260645-M17811110007 260605-M17811100020 260605-M17811100016 260605-M17811100010 260605-M17811100005 260645-M17811110002 260645-M17811110009 260605-M17811100007 260605-M17811100003 260605-M17811100008 260645-M17811110008 260645-M17811110005 260645-M17811110001 260605-M17811100012 260645-M17811110006 260645-M17811110004 260645-M17811110003 260605-M17811100019 260605-M17811100006 260605-M17811100009 260605-M17811100015 260605-M17811100011 260605-M17811100018 260605-M17811100014 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260645-M17C11480005 260645-M17C11480020 260645-M17C11480025 260645-M17C11480012 260645-M17C11480023 260605-M17C11490001 260605-M17C11490006 260605-M17C11490008 260605-M17C11490011 260605-M17C11490018 260645-M17C11480022 260645-M17C11480013 260605-M17C11490017 260645-M17C11480003 260645-M17C11480010 260645-M17C11480011 260645-M17C11480015 260645-M17C11480017 260645-M17C11480021 260645-M17C11480019 260605-M17C11490003 260605-M17C11490004 260605-M17C11490013 260645-M17C11480007 260645-M17C11480002 260645-M17C11480026 260605-M17C11490020 260645-M17C11480024 260605-M17C11490005 260605-M17C11490007 260605-M17C11490019 260645-M17C11480004 260645-M17C11480006 260645-M17C11480014 260605-M17C11490015 260645-M17C11480008 260645-M17C11480018 260645-M17C11480009 260605-M17C11490016 260605-M17C11490002 260605-M17C11490012 260605-M17C11490014 260605-M17C11490010 260605-M17C11490009 260605-M18108320014 260605-M18108320005 260605-M18108320004 260605-M18108320002 260605-M18108320015 260645-M18108330001 260605-M18108320019 260605-M18108... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Oct 24, 2025
- Center classification date
- Jan 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.