| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01325-1 |
| Product Name/Description |
Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System)
Serial Numbers: US23200375, US23200376, US23200377
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Upon power up, the IP5 may fail to produce audio. "Audio" includes touch screen tones, QRS/SpO2 modulation tones and audible alarms. All other functionality of the IP5 is unaffected (ie. waveforms, numeric values, visual alarm indications). This problem will only occur upon power up of the device. Accordingly, the scenario where audio is present at the onset of monitoring and then is lost during monitoring will not occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is providing users work around instructions to follow as an interim measure. A software update will be installed to correct the problem. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |