CLASS I ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

TruSignal Integrated Ear Sensor with GE Connector recalled

GE Healthcare Finland Oy is recalling TruSignal Integrated Ear Sensor with GE Connector. The recall was initiated on 19 May 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 00840682103138

Quantity recalled512 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2031-2023
FDA event ID: 92455
Recalling firm: GE Healthcare Finland Oy, Helsinki, N/A
Classification: Class I
Status: Ongoing
Recall initiated: 19 May 2023
FDA classified: 6 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

19 May 2023	Recall initiated by company
6 Jul 2023	Classified by FDA	+48 days
12 Jul 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

Where it was distributed

Worldwide

Questions about this recall

Is TruSignal Integrated Ear Sensor with GE Connector recalled?

Yes. GE Healthcare Finland Oy recalled TruSignal Integrated Ear Sensor with GE Connector on 19 May 2023. The recall is Class I and its status is Ongoing. Recall number Z-2031-2023.

Why was it recalled?

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

Which lots are affected?

GTIN 00840682103138

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare Finland Oy

All 13

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Carescape B450 recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Device Malfunction	Nationwide
19 Nov 2025Device	CLASS II	Battery Flex-3S2P 8V 18650 Li-ion Smbus used with patient monitors recalled	GE Healthcare Finland Oy	Device Malfunction	Nationwide
3 Jul 2024Device	CLASS II	Carescape Canvas Smart Display recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Device Malfunction
3 Jul 2024Device	CLASS II	Carescape Canvas Smart Display recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Device Malfunction
12 Jul 2023Device	CLASS I	TruSignal Ear Sensor recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Labeling Errors	N/A

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide