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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliVue MX40 Patient Monitor

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  Class 2 Device Recall IntelliVue MX40 Patient Monitor see related information
Date Initiated by Firm March 28, 2019
Create Date June 01, 2019
Recall Status1 Open3, Classified
Recall Number Z-1695-2019
Recall Event ID 82696
510(K)Number K113125  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All:
453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Code Information All revision B.X versions are affected.
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
FDA Determined
Cause 2		 Software design
Action On March 28, 2019, Philips Healthcare distributed URGENT MEDICAL DEVICE RECALL notices (FSN 86201863A) dated March 22, 2019 to customers via courier service. Actions To Be Taken by Customer/User at the time was as follows: - MX4O monitors can continue to be used while awaiting a software upgrade. - Customers should maintain an adequate supply of fully charged batteries given the approximately 25% increased power consumption. Switch to continuous or manual SO2 measurements if your unit is using automatic measurement mode. On April 24, 2019, Philips Healthcare distributed UPDATE URGENT MEDICAL DEVICE RECALL notices (FSN86201863B) dated April 16, 2019 to customers via courier service. Actions To Be Taken by Customer/User is currently as follows: Until you have upgraded the software on your MX4Os, replace your batteries every 8 hours, unless you are using continuous monitoring mode and Sp02 monitoring with AA batteries, in which case replacement should be done every 2 hours. Philips Healthcare will release a software upgrade, which will correct this problem. Philips will contact you to arrange for software correction. If you need any further information or support concerning this issue please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.
Distribution Worldwide distribution - US Nationwide and to 71 countries.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS
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