FDA Device recall Z-2535-2014
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System by Philips Medical Systems, citing 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 mult….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2535-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-07 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | CA, GA, NC, NH, NY, OR |
Product
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
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.
Identifiers
| code_info | Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051…Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2535-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.