Class 2 Device Recall IntelliVue MX40 Patient Monitor

• Date Initiated by Firm: September 19, 2016
• Create Date: October 20, 2016
• Recall Status: Terminated on May 25, 2018
• Recall Number: Z-0293-2017
• Recall Event ID: 75209
• 510(K)Number: K113125
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g; Product Number: 865352; ; 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 ; 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: Software design
• Action: The 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 Commerce: 2,212 units
• Distribution: Worldwide 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 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 = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS