FDA Device recall Z-0070-2021
Neoprobe GDS Control Unit, Model Number NPCU3
- FDA Device
- Class III
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class III recall of Neoprobe GDS Control Unit, Model Number NPCU3 by Devicor Medical Products, citing 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 Chin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0070-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-09-07 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Devicor Medical Products |
| Distribution | n/a |
Product
Neoprobe GDS Control Unit, Model Number NPCU3
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.
Identifiers
| code_info | UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123…UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2021%22
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