iM3 vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites potential cybersecurity issues raised in an FDA letter, with no stated defect consequence or reported harm.
Plain-English summary
The EDAN iM3 Vital Signs Monitor is being recalled by Edan Diagnostics. The record describes the product as follows: the iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters including non-invasive blood pressure and oxygen saturation.
The reason given in the enforcement record is that the firm received an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm's devices.
The record lists 11,987 units, with model, UDI-DI and serial or lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across a range of states listed in the record. The FDA has classified the action as Class II.
The record names no specific defect, consequence or reported harm. Facilities should follow Edan Diagnostics' instructions.
The recalled product
- 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)…
- Manufacturer
- Edan Diagnostics
- Affected units
- 11,987
Distribution
Part of a larger recall action
This product is one of 16 recalled by Edan Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Edan Diagnostics
See all →- ModerateTelemetry transmitters recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28
- ModerateFetal and maternal monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- HighEndoluminal vision probe bags recalled over compromised sterile pouch seals
FDA (Devices) · 2026-01-28
- ModerateiM8 series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateiM3s series vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
Same hazard · cybersecurity
See all →- ModerateiX series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateM3 vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateM3B vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
Similar recalls
- ModerateiM series patient monitors recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28
- ModerateiM20 patient monitors recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28
- ModerateMindray Accutorr 3 Vital Signs Monitor Recalled for Software Features
FDA (Devices) · 2019-11-06
- HighIntelliVue X3 measurement modules recalled over a potential failure to alarm
FDA (Devices) · 2025-12-10
- ModerateMindray Accutorr 7 Vital Signs Monitor Software Recall
FDA (Devices) · 2019-11-06
- ModerateMindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features
FDA (Devices) · 2019-11-06