Recall – Unapproved software version distributed

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)

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