HScribeRecalls & reported problems across all models
Mortara Instrument, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one HScribe model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of HScribe by Mortara Instrument, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Data Problem” (1 report).
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
HScribe 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 11, 2024Open, Classified
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Z-0320-2025 · Root cause: Software design · names 8 of these models · Recall details · FDA record ↗
Most reported HScribe problems
Device problems
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
HScribe models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HScribe HSERV-6AA-XXXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall1 report
- HScribe HSCRIBE-6AA-AAXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBE-6AA-AXXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBE-6AC-XXXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBE-6AA-AAXXEElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBE-6AC-AXXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBE-6AC-YXXXBElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
- HScribe HSCRIBWS-6AC-XXXXXElectrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
Recent HScribe adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Patient Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906106 ↗
Other Mortara Instrument, Inc. products
- ELI 38011 models · 109 reports · 2 recalls
- Q-Stress17 models · 12 reports · 2 recalls
- XScribe Cardiopulmonary Kit3 models · 0 reports · 2 recalls
- RScribe5 models · 0 reports · 1 recall
- XScribe2 models · 0 reports · 1 recall
- Vision Express4 models · 0 reports · 1 recall
- AM12M3 models · 0 reports · 1 recall
- Surveyor S192 models · 0 reports · 1 recall
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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