Class 2 Device Recall Philips IntelliVue Information Center iX (release A.00, A.01, and A.02)

• Date Initiated by Firm: December 19, 2014
• Date Posted: December 04, 2015
• Recall Status: Terminated on September 21, 2020
• Recall Number: Z-0374-2016
• Recall Event ID: 70000
• 510(K)Number: K102495
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:; 866023 IntelliVue Info Center iX; 866024 PIIC iX Upgrade; 866117 PIIC Classic Upgrade; ; The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. ; ; An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
• Code Information: Software systems Revision A.02.05 or lower
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
• FDA Determined Cause: Software Design Change
• Action: The firm, Philips Healthcare, issued a "URGENT-Field Safety Notice" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from Optional to Hidden 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. If you need any further information or support concerning this issue, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
• Quantity in Commerce: 10,013 units
• Distribution: Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, 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