Central monitoring systems recalled over potential cybersecurity issues flagged by FDA
Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System 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 MFM-CMS Central Monitoring System is being recalled by Edan Diagnostics. The record describes the product as follows: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices.
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 195 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: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring…
- Manufacturer
- Edan Diagnostics
- Affected units
- 195
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
- ModerateCMS8000 Patient Monitor Has Nine Cybersecurity Vulnerabilities
FDA (Devices) · 2025-05-21
- HighMindray DPM Central Station Recalled for Patient Data Anomaly
FDA (Devices) · 2013-01-09
- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- ModerateNihon Kohden CNS-6200 Central Nurse Station Recalled for Cybersecurity Vulnerability
FDA (Devices) · 2026-10-14