Food, drugs, devices › Volcano Corporation
Device recall: Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluati
Volcano Corporation (Rancho Cordova, CA) initiated this device recall on 22 Mar 2018; FDA lists 1 product record under event 79715, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 28 Apr 2021. Initiation: voluntary: firm initiated. Volcano Corporation has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Volcano Corporation, Rancho Cordova, CA.
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."
Distribution
"Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1891-2018 | 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. | 8 devices | Class II | Terminated | 23 May 2018 |
Context
Other enforcement events for Volcano Corporation
All 13 events for Volcano Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.