FDAFDA · Food and drugs·Recall number Z-2535-2014
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Published August 27, 2014 · Recall initiated: August 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
- Lot
- Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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