GE Healthcare Finland Oy: Medical Device Recall in 2023 - (Recall #: Z-2032-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 19, 2023

Date Posted: July 12, 2023

Recall Number: Z-2032-2023

Event ID: 92455

Reason for Recall:

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Status: Ongoing

Product Quantity: 2707 units

Code Information:

GTIN 00840682103428

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated