ClearanceBrief
Recall Z-0987-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Philips Healthcare Inc.

Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and p

DateJan 27, 2011 (initiated Dec 17, 2010)
StatusTerminated
ReasonSome 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.
Root causeDevice Design
ActionPhilips 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 n
Quantity1071
DistributionWorldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA WI, WV, WY, and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K081983M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
Philips Medical Systems, Aug 22, 2008