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)

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.