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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 October 10, 2018
Create Date December 10, 2018
Recall Status1 Open3, Classified
Recall Number Z-0592-2019
Recall Event ID 81531
510(K)Number K113125  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Code Information All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Support
800-722-9377
Manufacturer Reason
for Recall		 A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.
FDA Determined
Cause 2		 Vendor change control
Action On November 9, 2018, the firm notified customers of the issue via Customer Information Letters. The letter discussed the product problem. Customers are asked to confirm speaker behavior. It is recommended that the clinical user reboot the MX40 prior to entering Monitoring Mode to confirm proper operation of the speaker. Customers are also asked to complete the attached Reply Card and return to Philips as soon as possible. The firm will replace affected devices used at above 4,500 feet (1,372 meters). If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.
Quantity in Commerce 35469 units
Distribution US Nationwide distribution.
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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