TruSignal SpO2 TS-W-DRecalls & reported problems
GE Healthcare Finland Oy · TRUSIGNAL SPO2 TS-W-D · Class 2
All models of TruSignal SpO2 (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2029-2023 · Root cause: Device Design · Recall details · FDA record ↗
Other Oximeter, ear devices
- MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor 1895Masimo Corporation · Oximeter, ear1 recall3 reports
- MasimoSET® M-LNCS™ TC-I SpO2 Reusable Ear Sensor 2503Masimo Corporation · Oximeter, ear1 recall1 report
- Membrane Changer (reloadable) / single unit MC-RSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- TruSignal SpO2 TS-APGE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
- Portrait VSM MVC101Ge Medical Systems Information Technologies, Inc. · Oximeter, ear1 recall0 reports
- Membrane Changer Inserts MC-ISenTec AG · Oximeter, Ear1 recall0 reports
- MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor 1794Masimo Corporation · Oximeter, ear1 recall0 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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