FDA recall Z-2032-2023

Product

TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

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-2032-2023