Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Neoprobe GDS Control Unit, Model Number NPCU3

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Neoprobe GDS Control Unit, Model Number NPCU3 see related information
Date Initiated by Firm September 07, 2020
Create Date October 08, 2020
Recall Status1 Terminated 3 on May 09, 2023
Recall Number Z-0070-2021
Recall Event ID 86228
Product Classification Probe, uptake, nuclear - Product Code IZD
Product Neoprobe GDS Control Unit, Model Number NPCU3
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
Recalling Firm/
Manufacturer		 Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
For Additional Information Contact
513-864-9178
Manufacturer 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.
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 49
Distribution The products were distributed only to China.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-