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

TruSignal Wrap Sensor recalled by GE Healthcare Finland Oy

GE Healthcare Finland Oy is recalling TruSignal Wrap Sensor. 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 00840682103121

Quantity recalled5039 units

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-2029-2023
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 Wrap Sensor, REF TS-W-D; Oximeter

Where it was distributed

Worldwide

Questions about this recall

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 00840682103121

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

Other products in this recall event

8 other products · FDA event 92455

This product is part of a recall event; the main page for the event is TruSignal Sensitive Skin Sensor recalled by GE Healthcare Finland Oy.

Reported	Class	Recall	Company	Reason	Where
12 Jul 2023	CLASS I	TruSignal Sensitive Skin Sensor recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal AllFit Sensor: a) recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Integrated Ear Sensor with Ohmeda Connector recalled	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Integrated Ear Sensor with Datex Connector recalled	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Adult/Pediatric Sensor recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Integrated Ear Sensor with Datex Connector recalled	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Integrated Ear Sensor with GE Connector recalled	GE Healthcare Finland Oy	Labeling Errors	N/A
12 Jul 2023	CLASS I	TruSignal Ear Sensor recalled by GE Healthcare Finland Oy	GE Healthcare Finland Oy	Labeling Errors	N/A

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 10.8V 18650 Li-ion Smbus used 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

Other Patient Monitors recalls

All 1,013

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