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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 Monitorsee related information
Date Initiated by FirmApril 30, 2018
Create DateJune 11, 2018
Recall Status1 Terminated 3 on October 04, 2019
Recall NumberZ-2142-2018
Recall Event ID 80064
510(K)NumberK113125 
Product Classification Detector and alarm, arrhythmia - Product Code DSI
ProductIntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
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
ActionUrgent 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 Commerce7,178
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DSI
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