Reported Aug 27, 2014 · Terminated
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
- Lot codes and dates
- Model No. 860426
- Serial Numbers
US11400027US31400041US31400042US31400044US31400045US31400046US41400051US51300008US51400056US81300016USN1300020
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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