iM8 series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B 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 Patient Monitor models iM8, iM8A and iM8B is being recalled by Edan Diagnostics. The record describes the product as follows: the iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters and is capable of storing data.
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 3,141 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: 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 cont
- Manufacturer
- Edan Diagnostics
- Affected units
- 3,141
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
- ModerateiM3s series vital signs 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