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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 April 30, 2018
Create Date June 11, 2018
Recall Status1 Terminated 3 on October 04, 2019
Recall Number Z-2141-2018
Recall Event ID 80064
510(K)Number K113125  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Code Information All devices since release of B.05 (March 2016) prefix date code >/= US096
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
Manufacturer Reason
for Recall		 Five warning statements are missing from the instructions for use.
FDA Determined
Cause 2		 Error in labeling
Action Urgent Medical Device Correction notification letters were distributed on 4/30/18. The notification included the following instructions: Customers were asked to please review the information provided in the letter with all members of their staff who need to be aware of its contents. The letter provides information on the missing warnings and instructions for actions to be taken. The enclosed MX40 IFU Errata Sheet must be attached to the first page of Chapter 6 of the Instructions for Use for ready reference. Complete and return the attached Customer Reply Form.
Quantity in Commerce 25,499
Distribution Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.
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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