FDA Device recall Z-1150-2026
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring…
- 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: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring… 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-1150-2026 |
| 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: 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 information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. 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: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B…EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C0 |
|---|
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-1150-2026%22
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