Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810
FDA Recall Z-0451-2008 · Posted 2007-12-11
Advertisement
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMHX
Date Initiated2007-11-13
Date Terminated2016-08-15
Product Quantity60 units
Reason for Recall
Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group
Firm Action
Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer Care Contact telephone 1-800-722-9377)
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement