Recall Z-1891-2018 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
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.
| Date | May 17, 2018 (initiated Mar 22, 2018) |
| Status | Terminated |
| Reason | The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. |
| 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 pers |
| Quantity | 8 devices |
| Distribution | Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit Volcano Corporation, Oct 25, 2017 |