| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01052-1 |
| Product Name/Description |
Philips Expression Information Portal - IP5 (Multiparameter patient monitor)
Product Number: 865471
Serial Numbers: US23200375, US23200376, US23200377
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
If an IP5 is in use or powered on for an extended period of time (exceeding 24 hours), the IP5 may lost all audio function. "All audio" includes touch screen and QRS/SpO2 modulation tones and audible alarms. All other functionality of the IP5 is unaffected (waveforms, numeric values, visual alarm indications). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips representative will contact the affected customer to arrange for a software update to correct the problem. End users are requested to power cycle the IP5 once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |