GE Healthcare Finland Oy: Medical Device Recall in 2023 - (Recall #: Z-2026-2023)

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

Product Classification:

Class I

Date Initiated: May 19, 2023

Date Posted: July 12, 2023

Recall Number: Z-2026-2023

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: 23537 devices

Code Information:

a) REF TS-AP-10, GTIN 00840682103220 b) REF TS-AP-25, GTIN 00840682103220

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated