TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H — Class I medical device recall Z-2034-2023
Ongoing recall by GE Healthcare Finland Oy, reported 2023-07-12. There is a potential reduction of energy reaching patient during defibrillation, potential contact with uninte
| Recall number | Z-2034-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Finland Oy, Helsinki, N/A, Finland |
| Recall initiated | 2023-05-19 |
| Classified | 2023-07-06 |
| Reported by FDA | 2023-07-12 |
| Quantity | 237 devices |
| UPC / GTIN / UDI-DI | 00840682103367 |
| Model numbers | TS-E4-H |
Product
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Reason for recall
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2034-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.