Class II — Philips Medical Systems, Inc.
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 |
| 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. |
| Initiated | 2014-08-07 |
| Classified | 2014-08-21 |
| Terminated | 2015-10-21 |
| Recall number | Z-2535-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems, Inc. (Z-2535-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68983/
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