Device product

TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

Z-2028-2023

May 19, 2023

Class I

Product summary

Firm: GE Healthcare Finland Oy
Event: Event 92455
Status: Ongoing
Classification: Class I
Quantity: 2097 units
Official record key: device-enforcement:Z-2028-2023

Official wording

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

Code information: GTIN 00840682103282

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.