—#129200

Product

Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K120855
Affected lot / code info: Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.

Timeline

Recall initiated: 2014-08-07
Posted by FDA: 2014-08-21
Terminated: 2015-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129200. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.