TruSignal Wrap Sensor, REF TS-W-D; Oximeter
This recall is currently active, issued July 7, 2023. It was issued by Ge Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland.
- Recall Initiated
- May 19, 2023
- Posted
- July 7, 2023
- Recall Number
- Z-2029-2023
- Quantity
- 5039 units
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Distribution
Worldwide
Lot / Code Info
GTIN 00840682103121
Root Cause
Device Design
Action Taken
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.