FDA Device recall Z-1143-2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Sp…
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Sp… by Edan Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1143-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Edan Diagnostics |
| Distribution | US |
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. 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.
Identifiers
| code_info | EDAN Model: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B0666…EDAN Model: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 261436-M19B06650002 261436-M19B06660001 261436-M19B06660004 261436-M19B06650001 261436-M19B06660008 261436-M19B06660003 261436-M19B06660002 261436-M19B06660006 261436-M19B06650004 261436-M19B06660010 261436-M19B06660005 261436-M19B06660009 261436-M19C16980011 261436-M19C16980013 261436-M19C16980002 261436-M19C16980004 261436-M19C16980006 261436-M19C16980012 261436-M19C16980009 261436-M19C16980010 261436-M19C16980015 261436-M19C16980003 261436-M19C16980005 261436-M19C16980008 261436-M19C16980001 261436-M19C16980007 261436-M19C16980014 261436-M20707940016 261436-M20707940014 261436-M20707940008 261436-M20707940002 261436-M20707940020 261436-M20707940006 261436-M20707940004 261436-M20707940001 261436-M20707940012 261436-M20707940018 261436-M20707940009 261436-M20707940010 261436-M20707940011 261436-M20707940003 261436-M20707940005 261436-M20707940013 261436-M20707940 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.