| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00026-1 |
| Product Name/Description |
Philips IntelliVue Information Center (PIIC) iX
All PIIC iX Surveillance stations including:
866023 - IntelliVue Info Center iX A.0
866117 - PIIC Classic Upgrade
866389 - IntelliVue Info Center iX B.0, C.0
867141 - IntelliVue Info Center iX B.0
ARTG Number: 94237 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has been made aware of a potential problem with all PIIC iX Surveillance and Patient Link revisions. The issue will occur after a surveillance station is first restarted during the year 2018. After that initial restart, the station will thereafter no longer perform patient Discharge and Transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that in order to avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year.
Users may use the workflows described in the attachment provided with the customer letter to avoid operations that may cause the surveillance station to restart.
When a patient is discharged, confirm that the patient is discharged.
This action has been closed out on 05/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |