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U.S. Department of Health and Human Services

Class 2 Device Recall Diego Elite Blades Monopolar

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  Class 2 Device Recall Diego Elite Blades Monopolar 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-1186-2019
Recall Event ID 82451
510(K)Number K123429  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Diego Elite Blades Monopolar, 4mm Straight, TIA
Product Code:MB4000SS
Code Information All lot numbers
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 318
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.
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