iM3s series vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s after an FDA letter raising potential cybersecurity issues with the firm's devices.
What this means for you
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 Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s is being recalled by Edan Diagnostics. The record describes the product as follows: the iM3s series vital signs monitors, including iM3s, iM3As, iM3Bs and iHM3s, are intended to be used for measuring, storing and reviewing physiological parameters.
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 136 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: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
- Manufacturer
- Edan Diagnostics
- Affected units
- 136
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
- ModerateM3 vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
Same hazard · cybersecurity
See all →- ModerateM3B vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateiX series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateCentral monitoring systems recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28