AM12MRecalls & reported problems across all models

We found 3 models of AM12M by Mortara Instrument, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier.

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

AM12M 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.

1. Mar 31, 2021Terminated

   Devices do not meet IEC 60601-2-27 requirements as labeled.

   Z-1485-2021 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

AM12M models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AM12M 41000-037-50

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• AM12M 41000-037-51

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• AM12M 9293-065-50

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports

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
• HScribe8 models · 1 reports · 1 recall
• RScribe5 models · 0 reports · 1 recall
• XScribe2 models · 0 reports · 1 recall
• Vision Express4 models · 0 reports · 1 recall
• Surveyor S192 models · 0 reports · 1 recall