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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 February 02, 2021
Create Date May 21, 2021
Recall Status1 Terminated 3 on September 20, 2022
Recall Number Z-1671-2021
Recall Event ID 87829
510(K)Number K113125  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: 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 Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS)   UDI:  (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		 Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
FDA Determined
Cause 2		 Employee error
Action Philips Healthcare conducted site visits on 2/02/21 by Field Service Engineer and provided the customer with RMA to return affected devices. Devices retuned affected device on RMA. Device Replacement provided.
Quantity in Commerce 3 units
Distribution Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS
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