Recall Z-2535-2014 ยท DQK Computer, Diagnostic, Programmable
Philips Medical Systems, Inc.
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
| Date | Aug 21, 2014 (initiated Aug 7, 2014) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 11 units |
| Distribution | Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120855 | INTELLISPACE ECG Philips Health Care, Jun 29, 2012 |