Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2535-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 7, 2014

Date Posted: August 27, 2014

Recall Number: Z-2535-2014

Event ID: 68983

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated