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Recall Observatory FDA recall evidence

Device product

Neoprobe GDS Control Unit, Model Number NPCU3

Z-0070-2021

September 07, 2020

Class III

Product summary

Firm
Devicor Medical Products Inc
Event
Event 86228
Status
Terminated
Classification
Class III
Quantity
49
Official record key
device-enforcement:Z-0070-2021

Official wording

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.

Code information: 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

Distribution pattern: The products were distributed only to China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.