Recall Z-2027-2023— GE Healthcare Finland Oy

Name: FDA recall Z-2027-2023
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: K093881. Product: TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter. 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

K093881 — TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSORGE Healthcare Finland Oy·cleared 2010-03-12

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 AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

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.