Patient MonitorRecalls & reported problems across all models
Edan Instruments, Inc. · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Patient Monitor model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 6
We found 17 models of Patient Monitor by Edan Instruments, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Patient Monitor recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1154-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- 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-1149-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- 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-1148-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- 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-1147-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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-1146-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- 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-1145-2026 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗
Patient Monitor models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Patient Monitor iM8Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM8AMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM8BMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM50Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM80Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor elite V8Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM60Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM70Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor elite V5Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall0 reports
- Patient Monitor elite V6Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iM20Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor X8Oximeter1 recall0 reports
- Patient Monitor X10Oximeter1 recall0 reports
- Patient Monitor X12Oximeter1 recall0 reports
- Patient Monitor iX10Monitor, St Segment With Alarm1 recall0 reports
- Patient Monitor iX12Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Patient Monitor iX15Monitor, Breathing Frequency1 recall0 reports
Other Edan Instruments, Inc. products
All Edan Instruments, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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