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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 FirmSeptember 19, 2016
Create DateOctober 20, 2016
Recall Status1 Terminated 3 on May 25, 2018
Recall NumberZ-0292-2017
Recall Event ID 75209
510(K)NumberK113125 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPhilips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide except for the USA SW Revisions: B.05.28, B.05.29, and B.05.32 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 SW Revisions: B.05.28, B.05.29, and B.05.32
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
FDA Determined
Cause 2		Software design
ActionThe firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.
Quantity in Commerce1824 units
DistributionWorldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
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 = MHX
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