TruSignal SpO2 recallZ-2028-2023 · GE Healthcare Finland Oy · initiated May 19, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare Finland Oy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2028-2023
- Status
- Open, Classified
- Initiated by the company
- May 19, 2023
- Posted by the FDA
- Jul 7, 2023
- Recalling firm
- GE Healthcare Finland Oy
- Quantity
- 2097 units
- Product code
- DPZ
- FDA submissions
- K093881
- Distribution
- Worldwide
Product description
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Code information (models, lots, serial numbers)
GTIN 00840682103282
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TruSignal SpO2 TS-SE-3GE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92455).
- Z-2026-2023 · Open, ClassifiedTruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
- Z-2027-2023 · Open, ClassifiedTruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
- Z-2029-2023 · Open, ClassifiedTruSignal Wrap Sensor, REF TS-W-D; Oximeter
- Z-2030-2023 · Open, ClassifiedTruSignal Ear Sensor, REF TS-E-D; Oximeter
- Z-2031-2023 · Open, ClassifiedTruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
- Z-2032-2023 · Open, ClassifiedTruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
- Z-2033-2023 · Open, ClassifiedTruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
- Z-2034-2023 · Open, ClassifiedTruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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