Company: Devicor Medical Products Inc
Date of Enforcement Report: 10/14/2020
Class III
PRODUCT
Neoprobe GDS Control Unit, Model Number NPCU3
Recall Number: Z-0070-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Devicor Medical Products Inc on 9/7/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49
DISTRIBUTION
International (China)