FORE-SIGHT ELITE® 01-06-3100Recalls & reported problems
Cas Medical Systems, Inc. · Tissue Oximeter Preamp · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10609538631006), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143675); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AS REPORTED DURING USE THE FORESIGHT CABLE HAD INACCURATE PARAMETERS ON THE LEFT CHANNEL. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE IS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074942 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143675. One submission often covers many models, so check the product and lot details in each record.
- Z-0834-2022 · Mar 1, 2022 · Open, ClassifiedFORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Other Oximeter, Tissue Saturation devices
- INVOS PMAC71RSCCovidien LP · Oximeter, tissue saturation1 recall67 reports
- HEMOSPHERE FORESIGHT MODULE HEMFSM10Edwards Lifesciences LLC · Oximeter, Tissue Saturation1 recall12 reports
- INVOS PMAC71RICCovidien LP · Oximeter, tissue saturation1 recall4 reports
- FORE-SIGHT ELITE® 01-06-3000Cas Medical Systems, Inc. · Oximeter, Tissue Saturation1 recall1 death2 reports
- Invos 5100C-EUCovidien LP · Oximeter, tissue saturation22 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation21 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation18 reports
- INVOS 5100C-PACovidien LP · Oximeter, tissue saturation15 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 · each report above links to its original FDA record
- 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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