Device Recall Physiological Monitoring, Patient Monitor 의 리콜

Recall

57501

Class 2

Z-0987-2011

2010-12-17

2011-01-27

Terminated

United States

2017-04-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96439

Some pas-201 active speaker assemblies in use with the philips intellivue information center (piic) have experienced intermittent audio or loss of audio. speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.

Philips notified all affected customers with an Urgent Medical Device Correction notification letter dated December 17, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to observe their system for any of the described symptoms. If they experience intermittent audio or there is no sound from their PAS-210 speaker while it is not connected to another audible alarm annunciation system, customers were instructed to remove the speaker from use and contact their local Philips service representative. Customers were advised not to rely exclusively on the audible alarm system for patient monitoring, the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. ACTIONS PLANNED BY PHILIPS Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative would contact the customer when the replacement was available. Field Service Engineers will remove and replace defective speakers to correct the problem. The defective speakers will be returned to vendor (Beach Wire) to be discarded. This correction will be done free of charge for customers.