—#66252

Product

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 product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K062271
Affected lot / code info: Serial Numbers: 4711A00132 4725A02724 4711A00354 4725A02791 4716A00562 4725A02897 4717A00702 4725A02927 4717A00703 4725A03255 4717A00705 4732A03719 4717A00706 4732A03725 4717A00724 4732A03764 4717A00725 4732A03765 4717A00799 4732A03766 4717A00857 4732A04028 4718A00957 4732A04031 4718A01077 4732A04134 4718A01078 4732A04178 4718A01120 4732A04400 4718A01121 4732A04623 4718A01454 4732A04671 4721A01670 4732A04675 4721A01711 4732A04746 4721A01731 4732A04868 4721A01773 4732A04869 4721A01797 4732A04870 4721A01828 4732A04871 4721A01919 4732A04872 4721A01993 4732A04873 4721A01994 4732A04874 4721A01997 4732A04875 4721A02164 4732A04876 4725A02354 4732A04877 4732A04890 4732A04896

Why it was recalled

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

Root cause (FDA determination)

Software change control

Action the firm took

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)

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

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.

Timeline

Recall initiated: 2007-11-13
Posted by FDA: 2007-12-11
Terminated: 2016-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.