Device Recall PIIC iX Intellivue iX Information Center Software 의 리콜

Recall

79132

Class 2

Z-0776-2018

2018-01-03

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161421

Once a surveillance station is restarted on january 1, 2018 or later, the station will be unable to 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. until this issue can be corrected, users should avoid intentionally restarting their surveillance stations in 2018.

To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged. Philips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th. A Philips Healthcare representative will contact customers with affected devices to arrange for correction of the issue. Contact your local Philips representative if you have a question about any device affected by this issue.