Skip to content
Recall Observatory FDA recall evidence

Device product

Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426

Z-2535-2014

August 07, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 68983
Status
Terminated
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2535-2014

Official wording

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.

Code information: Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020

Distribution pattern: Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.