Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The ... — FDA record Z-1145-2026
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: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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. 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
- 14550
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1145-2026
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: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 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262057-M20B12950006 262057-M20B1... |
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.