Recall Z-2030-2023 ยท DPZ Oximeter, Ear
GE Healthcare Finland Oy
TruSignal Ear Sensor, REF TS-E-D; Oximeter
| Date | Jul 7, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 10451 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE Healthcare Finland Oy, Mar 12, 2010 |