Model Eagle II, MRIRecalls & reported problems across all models
Zoll Medical Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Model Eagle II, MRI model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 128
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Model Eagle II, MRI by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 128 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2017 and Jun 10, 2026 — classified as 128 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (34 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
Model Eagle II, MRI 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.
- Apr 30, 2024Open, Classified
Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy
Z-2130-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Model Eagle II, MRI problems
Device problems
- Failure of Device to Self-Test34
- Mechanical Problem32
- Calibration Problem23
- Communication or Transmission Problem13
- Device Displays Incorrect Message11
- Improper Flow or Infusion6
- Failure to Power Up5
- Unexpected Shutdown5
Patient problems
- No Patient Involvement59
- No Clinical Signs, Symptoms or Conditions39
- No Information16
- No Consequences Or Impact To Patient8
- Insufficient Information5
- Intraoperative Cardiac Valve Injury1
Model Eagle II, MRI models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Model Eagle II, MRI 799-EGL2-02VENTILATOR, CONTINUOUS, FACILITY USE1 recall64 reports
- 1 recall64 reports
Recent Model Eagle II, MRI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "COMPRESSOR FAULT 2001 AND 3001 " ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456775 ↗MalfunctionJan 5, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23964955 ↗MalfunctionOct 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE- 1474" AND "INTERNAL COMM FAILURE - 1472" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360261 ↗MalfunctionSep 29, 2025Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAULT" ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23168755 ↗MalfunctionFeb 18, 2025Activation Problem; Activation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DID NOT RESPOND TO THE ROTARY KNOB SELECTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405184 ↗MalfunctionJan 2, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE HALTS AFTER PARTIAL BOOT CYCLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057879 ↗MalfunctionOct 28, 2024Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543886 ↗MalfunctionOct 25, 2024Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: Intraoperative Cardiac Valve Injury
MAUDE report 20534756 ↗MalfunctionOct 18, 2024Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED VENTILATING. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 20479878 ↗MalfunctionSep 10, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAULT - 2001" AND "COMPRESSOR FAULT - 3001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181219 ↗MalfunctionJun 28, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "COMPRESSOR FAULT - 2001" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632449 ↗MalfunctionMay 1, 2024Calibration Problem; Improper Flow or Infusion; Calibration Problem; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED VENTILATING AND DISPLAYED A" RUNTIME CALIBRATION FAILURE - 1051" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226229 ↗MalfunctionApr 25, 2024Calibration Problem; Failure of Device to Self-Test; Calibration Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "RUNTIME CALIBRATION FAILURE - 1051" AND "OFF SET SELF CHECK FAILURE - 1174" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19184069 ↗MalfunctionApr 15, 2024Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE - 1001" AND "SELF CHECK FAILURE - 1003" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19104080 ↗MalfunctionApr 1, 2024Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "SELF CHECK FAILURE - 1003" AND "COMPRESSOR FAILURE - 1001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19012617 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- M SERIES BIPHASIC59 models · 572 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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