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Devicor Medical Products Inc recalls Neoprobe GDS Control Unit, Model Number NPCU3
Recalled October 14, 2020 · FDA recall Z-0070-2021 · Devicor Medical Products
Hazard
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. · FDA Class III
Units
49
Sold at
The products were distributed only to China.
Description
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.
Product
Neoprobe GDS Control Unit, Model Number NPCU3
Manufacturer(s)
Devicor Medical Products Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →