FDA recall Z-1891-2018

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 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.

Key facts

Status

Terminated

Initiation date

2018-03-22

Report date

2018-05-23

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rancho Cordova, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2018