Central Monitoring System MFM-CNSRecalls & reported problems
Edan Instruments, Inc. · Class 2
All models of Central Monitoring System (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Oct 24, 2025Class IIOpen, Classified
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.
Z-1151-2026 · Root cause: Device Design · Recall details · FDA record ↗
Other System, Monitoring, Perinatal devices
- Avalon Fetal Monitor FM30 Avalon FM30 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL1 recall11 deaths142 reports
- Avalon Fetal Monitor FM20 Avalon FM20 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL1 recall126 reports
- Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbH · System, Monitoring, Perinatal1 recall2 deaths41 reports
- Avalon Fetal Monitor FM50 Avalon FM50 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL9 deaths51 reports
- Central Monitoring System MFM-CNS LiteEdan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Fetal & maternal monitor F6 ExpressEdan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Fetal & maternal monitor F9Edan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Fetal & maternal monitor F6Edan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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