Philips Volcano CORE M2 Vascular System — Class II medical device recall Z-1891-2018
Terminated recall by Volcano Corporation, reported 2018-05-23, distributed in CA, CT, MD, NC, OR, TN. The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an
| Recall number | Z-1891-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2018-03-22 |
| Classified | 2018-05-17 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2021-04-28 |
| Distributed | CA, CT, MD, NC, OR, TN |
| Countries outside the US | AU |
| Quantity | 8 devices |
| UPC / GTIN / UDI-DI | 00126620101597 |
| Serial numbers | 126620093077, 126620100718, 126620101597, 126620101599, 126620101600, 126620102307, 126620102313, 126620102315 |
| Model numbers | 400-0100.17 |
Product
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
Reason for recall
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
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-1891-2018. 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.