FDA Device recall Z-2027-2023
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs
- FDA Device
- Class I
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class I recall of TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs by Ge Healthcare Finland Oy, citing there is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2027-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-19 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare Finland Oy |
| Distribution | n/a |
Product
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Reason
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Identifiers
| code_info | a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2027-2023%22
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