FDA recall Z-2031-2023

GE Healthcare Finland Oy · Class I · device

Product

TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

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-2031-2023