Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/27/2014
Class lI:
PRODUCT
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Recall Number Z-2535-2014
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/MANUFACTURER
Philips Medical Systems, Inc ,Andover, MA on 8/7/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11 Units
DISTRIBUTION
Nationwide and Internationally
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