Neoprobe GDS Control Unit (Devicor) - Software version issue (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neoprobe GDS Control Unit, Model Number NPCU3
Brand
Devicor Medical Products Inc
Lot Codes / Batch Numbers
UDI: 00841911100317
Products Sold
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
Devicor Medical Products Inc is recalling Neoprobe GDS Control Unit, Model Number NPCU3 due to 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 o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
URGENT FIELD CORRECTION notification letters were sent to customers. Action to be taken by the user: As a result of this notification, please conduct the following: " Please Examine your inventory, identify and reference attached product list to determine if you have an affected device. " If you have any Devices referenced, immediately contact Minghui Qian at +86 21 8031 6329 " If in use on a patient, continue to use the device if an alternative device is not available. " Please complete and return the enclosed Response Form of Acknowledgement. " If you have any additional questions, comments or concerns please contact our Customer Support at +86 21 8031 6329. You may also email mmtchnrecall@mammotome.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026