Class 2 Device Recall Philips IntelliSpace ECG Management System

• Date Initiated by Firm: August 07, 2014
• Date Posted: August 21, 2014
• Recall Status: Terminated on October 21, 2015
• Recall Number: Z-2535-2014
• Recall Event ID: 68983
• 510(K)Number: K120855
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System.; ; Model No. 860426
• Code Information: Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Same; 978-687-1501
• Manufacturer Reason for Recall: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
• FDA Determined Cause: Software design
• Action: Philips Healthcare sent an Urgent Medical Device Correction Notification / Field Safety notice dated August 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the issue is and under what conditions it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients " the corrective action planned by Philips to address the following issue 1)Previously Imported Stress Records: Institutions that have imported Quinton Stress ECG records into IECG should review each previously imported record to make sure that multiple patient ID data is not present. Institutions that imported stress records at the end of each stress exam or did not batch process the records should not find any records with multiple Patient IDs in the record. However, we do recommend that you perform the review to confirm that multiple Patient IDs do not exist. 2) Continued Use: Software is now available to address the issue described in this letter. If you have not already been contacted by Philips please call to arrange for immediate installation of the software upgrade. The correction will consist of free of charge software upgrade to A.01.06.. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377
• Quantity in Commerce: 11 units
• Distribution: Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
• 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 = DQK and Original Applicant = PHILIPS HEALTHCARE