Philips Healthcare IntelliVue Info Center iX — Class II medical device recall Z-0858-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-03-02, distributed nationwide. Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in sp
| Recall number | Z-0858-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, DE, DK, DZ, EE, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KE, KR, KW, LU, MA, MY, NG, NL, NO, NZ, PL, QA, RO, SA, SE, SG, SI, TR, TW, ZA |
| Quantity | 1,880 units |
Product
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Reason for recall
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
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-0858-2016. 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.