FDA recall Z-0070-2021

Product

Neoprobe GDS Control Unit, Model Number NPCU3

Reason for recall

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.

Distribution

The products were distributed only to China.

Key facts

Status

Terminated

Initiation date

2020-09-07

Report date

2020-10-14

Termination date

2023-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2021