| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01129-1 |
| Product Name/Description |
Philips IntelliVue Monitors with Nellcor SpO2 Boards
Product numbers: M3001A (862442), M3002A (M865039), M8102A (865040), M8105A (865024), M8105AT (865120), M8105AS (865322)
Devices manufactured prior to 27 Sep 2018
ARTGs: 118076 & 213953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2022 |
| Responsible Entity |
|
| Reason/Issue |
Customers using specific IntelliVue Monitors with Nellcor SpO2 Boards may experience loss of SpO2 function in older devices, during normal use.
Over time, normal use of the device may cause board components to drift towards the edge of the specified tolerance. This may cause a board operational issue that will result in failure of the SpO2 monitoring function. An “SpO2 equipment malfunction” technical alarm will be triggered by this event.
This condition does not impact monitoring of other parameters such as ECG, heart rate, respiratory rate, non-invasive blood pressure, temperature, invasive pressures, and end tidal CO2. Additionally, therapies being delivered to the patient are not affected.
There have been no reports of patient injury or death associated with these complaints globally. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Patient monitors may continue to be used as normal until issue occurs.
If "SpO2 equipment malfunction" technical alarm is observed, contact Philips to arrange a service.
Philips recommends users have an alternate SpO2 monitoring device available. If the described behaviour is observed in one of more devices, Philips will proactively replace all Nellcor SpO2 boards in affected Philips IntelliVue monitors in each facility.
Philips will replace Nellcor SpO2 boards in affected Philips Intellivue devices in facilities who do not have back up devices available. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |