TruSignal SpO2 TS-SE-3Recalls & reported problems
GE Healthcare Finland Oy · SENSOR ASSEMBLY TS-SE-D · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 19, 2023Open, Classified
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2028-2023 · Root cause: Device Design · FDA record ↗
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- MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor 1794Masimo Corporation · Oximeter, ear1 recall0 reports
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
- Portrait VSM MVC101Ge Medical Systems Information Technologies, Inc. · Oximeter, ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer Inserts MC-ISenTec AG · Oximeter, Ear1 recall0 reports
- TruSignal SpO2 TS-W-DGE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.