FDA-Device2014-08-27Class II
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Philips Medical Systems, Inc.
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.
Sold states
Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
Affected count
11 units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2014Don't want to check this manually?
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