FDA Device Recall Z-2027-2023

GE Healthcare Finland Oy · Helsinki, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176

Quantity: 36337 devices

Reason for recall

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

Recall record

Recall number: Z-2027-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2023-05-19
Classified by FDA Center: 2023-07-06
FDA published: 2023-07-12
Recalling firm: GE Healthcare Finland Oy
Firm location: Helsinki, N/A, Finland

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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