Device Recall Philips IntellVue Info Center 의 리콜

Recall

64507

Class 2

Z-1783-2014

2013-03-05

2014-06-11

Terminated

United States

2017-05-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116367

If a customer creates customized trend scales in the trend review tile and the ix or primary server reboots for any reason, the ix(s) will enter a reboot loop. if one ix reboots, the issue will impact only those patients monitored on that device. if the primary server reboots, all patients across all ix devices will be impacted.

On 3/5/13, Philips sent each known affected customer an Urgent Medical Device Correction notification/Field Safety Notice to inform them that Philips has received a customer report that the PIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. In order to prevent this from occurring, customers were advised to not modify/customize the default trend scales for reviewing stored patient data in the retrospective review applications. Recall letter also states that a Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIX iX software resolving this issue on affected units. Philips will conduct these updates for all affected devices at no charge.