Z-2031-2023Class I

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

Name: Z-2031-2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
Creator: GE Healthcare Finland Oy
Published: 2023-05-19
License: https://open.fda.gov/license/

GE Healthcare Finland Oy / initiated 2023-05-19 / Open, Classified / root cause: design

FDA source

GE Healthcare Finland Oy began a recall of TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear on 2023-05-19. FDA classified it as Class I and gives the reason as "There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2031-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-07-07
Recalling firm: GE Healthcare Finland Oy
Product: TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
Product code: DPZ Oximeter, Ear
Reason for recall: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice on 05/19/2023. The notice explained the safety issues associated with the us of the device and requested the actions be taken: Actions to be taken by Customer/User for Safety Issue # 1 and #2: 1. Use an alternate method for SpO2 monitoring such as TruSignal Sensors not impacted by this field action, or an alternate SpO2 device, if possible 2. If alternate methods are not possible, the affected TruSignal SpO2 Sensors can be used for monitoring if they have not been saturated with fluids 3. If defibrillation is necessary, when the affected TruSignal SpO2 Sensors are being used, please follow the instructions below: I. Remove the affected TruSignal SpO2 Sensor (see Table 1 below) from the patient II. Defibrillate the patient, per hospital protocol III. Reattach the affected TruSignal SpO2 Sensor after defibrillation is no longer needed Actions to be taken by Customer/User for Safety Issue #3: 1. Before using Adult/Pediatric SpO2 Sensors (see Table 1), confirm that the sensor does not contain additional material covering the emitter or detector. 2. If any additional material is present, discard the sensor and select another sensor.
Quantity in commerce: 512 devices
Distribution: Worldwide
Product codes and lots: GTIN 00840682103138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2031-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2026-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2027-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2028-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2029-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2030-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2031-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2032-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2033-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2034-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06

Product code DPZ

K040831Class IIDatex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. / cleared 2004-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)