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 Olympus Diego Elite Console

  • 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 Olympus Diego Elite Console see related information
Date Initiated by Firm March 08, 2019
Create Date April 17, 2019
Recall Status1 Terminated 3 on May 08, 2020
Recall Number Z-1178-2019
Recall Event ID 82451
510(K)Number K123429  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Olympus Diego Elite Console
MDCONS 100
Code Information Consoles containing software UIC version 2.3.9.0 and RTC version 00.01.23 US Serial Numbers: GB00197 GB02851 GB04383 GB00235 GB02878 GB04384 GB00238 GB02995 GB04386 GB00270 GB03000 GB04400 GB00278 GB03054 GB04401 GB00280 GB03171 GB04412 GB00870 GB03173 GB04414 GB00886 GB03201 GB04416 GB00917 GB03232 GB04417 GB00925 GB03431 GB04419 GB00937O GB03519 GB04420 GB00949 GB03675 GB04481 GB02173 GB03714 GB04482 GB02250 GB03717 GB04483 GB02263 GB03733 GB04484 GB02268 GB03746 GB04485 GB02289 GB03782 GB04486 GB02366 GB03790 GB04488 GB02368 GB03791 GB04489 GB02372 GB03793 GB04490 GB02381 GB03923 GB04491 GB02390 GB03941 GB04496 GB02406 GB03961 GB04497 GB02422 GB03966 GB04498 GB02442 GB04008 GB04503 GB02446 GB04022 GB04506 GB02453 GB04035 GB04507 GB02457 GB04041 GB04515 GB02507 GB04195 GB04516 GB02538 GB04212 GB04517 GB02539 GB04214 GB04534 GB02602 GB04241 GB04540 GB02613 GB04243 GB04592 GB02716 GB04246 GB02807 GB04315 GB02808 GB04338 GB04367  OUS: GB03672 GB02338 GB02414 GB02863 GB00205 GB02324 GB02719 GB02933 GB02955 GB03799 GB02172 GB02460 GB02204 GB00857 GB00907 GB02928 GB00876 GB02413 GB00850 GB00879 GB00852 GB02466 GB02584 GB00698 GB02580 GB00904 GB02924 GB02930 GB00844 GB03946 GB03747 GB03226 GB03550 GB02940 GB02582 GB03432 GB04013 GB00959 GB03983 GB02655 GB02694 GB02576 GB02704 GB02925 GB02193 GB02216 GB00180 GB04244 GB00206 GB00266 GB00837 GB02463 GB00267 GB00848 GB00873 GB00821 GB03007 GB02558 GB00822 GB03233 GB02480 GB02569 GB02833 GB02559 GB02563 GB02557 GB00833 GB00702 GB02560 GB02656 GB02658 GB03005 GB02565 GB02500 GB02573 GB03677 GB02561 GB04204 GB03819 GB03921 GB02805 GB02282 GB02594 GB03189 GB02593 GB03716 GB04023 GB02659 GB02861 GB00700 GB03043 GB02283 GB03045 GB02568 GB00830 GB02889 GB03162 GB02567 GB02511 GB03023 GB03530 GB02304 GB02461 GB02519 GB02465 GB02415 GB02308 GB02328 GB02518 GB02325 GB02313 GB02494 GB04347 GB00897 GB02336 GB02579 GB00919 GB02196 GB00964 GB02194 GB00269 GB00899 GB00969 GB02280 GB02443 GB02864 GB03522 GB02217 GB03984 GB03207 GB00854 GB02497 GB02445 GB02517 GB02326 GB02299 GB02316 GB02501 GB02299 GB02316 GB02501 GB03800 GB03956 GB04543 GB04531 GB04536 GB04538 GB04518 GB04519 GB04520 GB04492 GB04493 GB04494 GB04495 GB04411 GB04413 GB04487 
Recalling Firm/
Manufacturer		 Gyrus ACMI, Inc.
2925 Appling Rd
Bartlett TN 38133-3901
For Additional Information Contact
901-373-0200 Ext. 4251
Manufacturer Reason
for Recall		 Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
FDA Determined
Cause 2		 Software design
Action Olympus issued a voluntary field action on March 8, 2019 via letter and reply form sent to all consignees informing them of the risk and requiring them to take action as follows: c. Consignees in the United States using MDCONSlOO consoles with the affected software wiIl be instructed to cease using the consoles. Replacement consoles that do not utilize the affected software will be made available on an interim basis until updated software is made available, and can be loaded into the affected consoles by Olympus Field Service personnel. d. OUS Consignees instructed to remove the affected blades currently in their possession from use, and returned to Olympus. Replacement blades will be sent to these consignees as soon as the process flow changes to the respective production lines are implemented, and inspections of blade inventory in Olympus' possession are completed. e. All affected consoles will be loaded with updated software as soon as it is available.
Quantity in Commerce US: 107 consoles, OUS: 157 consoles
Distribution Nationwide Foreign: Germany,Japan, Singapore
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS ACMI, INC.
-
-