Z-0987-2011

Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H...

Name: Z-0987-2011 Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H...
Creator: Philips Healthcare Inc.
Published: 2010-12-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-12-17 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information... on 2010-12-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0987-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-01-27
Terminated: 2017-04-18
Recalling firm: Philips North America LLC
Product: 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 provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1071
Distribution: Worldwide 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
Product codes and lots: serial #s KVN 0001 through KVN 1071

Product code MHX

K081983Class IIM3290a Intellivue Information Center Software, Release 1.00Philips Medical Systems / cleared 2008-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)