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Recall Observatory FDA recall evidence

Device product

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

Z-2027-2023

May 19, 2023

Class I

Product summary

Firm
GE Healthcare Finland Oy
Event
Event 92455
Status
Ongoing
Classification
Class I
Quantity
36337 devices
Official record key
device-enforcement:Z-2027-2023

Official wording

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

Code information: a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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