Recall Z-2031-2023— GE Healthcare Finland Oy

Name: FDA recall Z-2031-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class I · Ongoing

Class I FDA medical device recall by GE Healthcare Finland Oy, initiated 2023-05-19. It names one FDA 510(k) clearance: K040831. Product: TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear. Reason: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement..

Recalling firm: GE Healthcare Finland Oy
Classification: Class I
Status: Ongoing
Initiated: 2023-05-19
Firm location: Helsinki, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K040831 — DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.·cleared 2004-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.