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 2 Device Recall Restore Clinician Programmer Application Software

  • 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 2 Device Recall Restore Clinician Programmer Application Softwaresee related information
Date Initiated by FirmJuly 17, 2020
Date PostedSeptember 29, 2023
Recall Status1 Terminated 3 on September 27, 2024
Recall NumberZ-2657-2023
Recall Event ID 92798
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductRestore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Code Information Version 1.0.4232, UDI-DI 00763000273668.
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact
800-962-9888
Manufacturer Reason
for Recall		The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
FDA Determined
Cause 2		Software design
ActionLetters dated July 2020 and flagged as "URGENT: MEDICAL DEVICE CORRECTION RESTORE CLINICIAN PROGRAMMER APPLICATION SOFTWARE UPDATE Model A71100" were issued via USPS Priority First Class Mail on 7/17/2020. The letter provided an issue summary and informed the consignee the updated version of the A71100 application was now available for download and installation for resolving the issue. The consignee was to follow the instructions provided with the letter to update the application and if assistance was needed, contact information was provided for the Technical Services team support. Once the required update is made, the action will be tracked through the firm's mobile software deployment systems and no additional reply was needed from the consignee. The letter also explained patient risk, how to identify the issue, and conditions resulting in the issue. The letter was to be shared as appropriate with those in the consignee's organization who require the information.
Quantity in Commerce2,408 devices
DistributionWorldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Total Product Life CycleTPLC 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.
-
-