# FDA recall Z-2027-2023

> **GE Healthcare Finland Oy** · Class I · device recall initiated 2023-05-19.

## Product

TruSignal AllFit Sensor:    a) REF TS-AF-10, 10 pcs;   B) REF AF-25, 25 pcs; Oximeter

## Reason for recall

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2027-2023
- **Recalling firm:** GE Healthcare Finland Oy
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-19
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Helsinki, N/A, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2027-2023

## Citation

> AI Analytics. FDA recall Z-2027-2023. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-2027-2023. Source: US FDA. Licensed CC0.

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