FDA Device recall Z-1891-2018
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only by Volcano, citing the incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1891-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-22 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Volcano |
| Distribution | CA, CT, MD, NC, OR, TN |
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
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Identifiers
| code_info | Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2018%22
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