Z-1891-2018Class II

Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and...

Name: Z-1891-2018 Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and...
Creator: Volcano Corporation
Published: 2018-03-22
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2018-03-22 / Terminated

FDA source

Volcano Corporation began a recall of Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the... on 2018-03-22. FDA classified it as Class II and gives the reason as "The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1891-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-22
Posted: 2018-05-17
Terminated: 2021-04-28
Recalling firm: Volcano Corporation
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
FDA root cause: Other
Action: Customers were notified on 03/21/2018. U.S. customers were notified via hand-delivered Urgent Medical Device Recall letters; foreign customer letter was mailed. The letter identified the affected device and the reason for the recall. Instructions included to stop usage of the device and to call remote support at 1-800-228-4728, to schedule a visit to replace the affected device. Customers were instructed to complete and return the customer response form or to provide the form to Philips representatives. Customers were also instructed to provide copies of the recall notification to all personnel within their organization who handled this device.
Quantity in commerce: 8 devices
Distribution: Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
Product codes and lots: Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1891-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-17

Product code IYO

K172455Class IICORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitVolcano Corporation / cleared 2017-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)