Home / Recalls / GE Healthcare Finland Oy / Z-2031-2023

Z-2031-2023 Class I Ongoing

Recalled by GE Healthcare Finland Oy — Helsinki, N/A

Recall Details

Product Type
Devices
Report Date
July 12, 2023
Initiation Date
May 19, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
512 devices

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.

Distribution Pattern

Worldwide

Code Information

GTIN 00840682103138

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  • Z-0455-2026 Class II — B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600 (September 26, 2025)
  • Z-0456-2026 Class II — Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With (September 26, 2025)
  • Z-0453-2026 Class II — Carescape B450, Model no. 5805686 - shipped with potentially affected batteries (September 26, 2025)
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  • Z-2170-2024 Class II — CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAE (April 5, 2024)
  • Z-2171-2024 Class II — CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2 (April 5, 2024)
  • Z-2169-2024 Class II — CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) (April 5, 2024)
  • Z-2172-2024 Class II — CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) (April 5, 2024)