CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Philips Volcano CORE M2 Vascular System, Part # recalled
Volcano is recalling Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, distributed in California, Connecticut, Maryland, North Carolina, Oregon, Tennessee. The recall was initiated on 22 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1891-2018
- FDA event ID
- 79715
- Recalling firm
- Volcano, Rancho Cordova, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2018
- FDA classified
- 17 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 22 Mar 2018 | Recall initiated by company | |
| 17 May 2018 | Classified by FDA | +56 days |
| 23 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
Questions about this recall
Why was it recalled?
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Which lots are affected?
Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
Where was it sold?
Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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