Philips IntelliSpace ECG Management System recall
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Why was Philips IntelliSpace ECG Management System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020
- Product
- Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 11 units
- Distribution
- Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)