FDA Medical Device Recalls (openFDA)
GE Healthcare Finland Oy: TruSignal Wrap Sensor, REF TS-W-D; Oximeter
- Recall number
- Z-2029-2023
- Recalling firm
- GE Healthcare Finland Oy
- Product
- TruSignal Wrap Sensor, REF TS-W-D; Oximeter
- Status
- Open, Classified
- Initiated
- 2023-05-19
- Posted
- 2023-07-07
- Terminated
- not on file
- Reason
- There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- 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
- 5039 units
- Distribution
- Worldwide
- Lot, serial or model codes
- GTIN 00840682103121
- 510(k) numbers
- ["K093881"]
- PMA numbers
- not on file
- Product code
- DPZ
- Firm FEI
- 3002806783
- Firm city
- Helsinki
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28