FDA Device recall Z-2026-2023
TruSignal Adult/Pediatric Sensor
- FDA Device
- Class I
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class I recall of TruSignal Adult/Pediatric Sensor 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-2026-2023 |
| 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 Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
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-AP-10, GTIN 00840682103220 b) REF TS-AP-25, GTIN 00840682103220 |
|---|
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-2026-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.