FDA recall Z-2026-2023

Product

TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

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

Status

Ongoing

Initiation date

2023-05-19

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Helsinki, N/A, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2026-2023