Recall Z-2535-2014— Philips Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-08-07, terminated 2015-10-21. It names one FDA 510(k) clearance: K120855. Product: Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426. 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..
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-07
- Terminated
- 2015-10-21
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.