Z-2535-2014Class II

Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton...

Name: Z-2535-2014 Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton...
Creator: Philips Medical Systems, Inc.
Published: 2014-08-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-08-07 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 on 2014-08-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2535-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-07
Posted: 2014-08-21
Terminated: 2015-10-21
Recalling firm: Philips North America LLC
Product: Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root 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.
Product codes and lots: Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2535-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2535-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21

Product code DQK

K120855Class IIIntellispace ECGPhilips Health Care / cleared 2012-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)