Company: Devicor Medical Products Inc
Date of Enforcement Report: 10/14/2020
Neoprobe GDS Control Unit, Model Number NPCU3
Recall Number: Z-0070-2021
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Devicor Medical Products Inc on 9/7/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE