Class 2 Device Recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (P

• Date Initiated by Firm: May 22, 2014
• Date Posted: June 10, 2014
• Recall Status: Terminated on May 16, 2018
• Recall Number: Z-1746-2014
• Recall Event ID: 68349
• 510(K)Number: K103646 K113125
• Product Classification: Monitor,physiological,patient (with arrhythmia detection or alarms - Product Code MHX
• Product: IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
• Code Information: Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Peter Ohanian; 800-722-9377
• Manufacturer Reason for Recall: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
• FDA Determined Cause: Software design
• Action: On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a free of charge software upgrade. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: The following two items must be configured when using MX40 with the IntelliVue Information Center iX: 1. Utilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms Utilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device
• Quantity in Commerce: 42,600
• Distribution: United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
• 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; 510(K)s with Product Code = MHX and Original Applicant = PHILLIPS MEDICAL SYSTEMS