Philips IntelliSpace ECG Management System — Class II medical device recall Z-2535-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-08-27, distributed in CA, GA, NC, NH, NY, OR. Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress
| Recall number | Z-2535-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-08-07 |
| Classified | 2014-08-21 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-10-21 |
| Distributed | CA, GA, NC, NH, NY, OR |
| Countries outside the US | CA, ES |
| Quantity | 11 units |
| Serial numbers | US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020 |
| Model numbers | 860426 |
Product
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2535-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.