Date Initiated by Firm | March 08, 2019 |
Create Date | April 17, 2019 |
Recall Status1 |
Terminated 3 on May 08, 2020 |
Recall Number | Z-1181-2019 |
Recall Event ID |
82451 |
510(K)Number | K123429 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part No: BB4000SC |
Code Information |
All lot numbers |
Recalling Firm/ Manufacturer |
Gyrus ACMI, Inc. 2925 Appling Rd Bartlett TN 38133-3901
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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 | 82 |
Distribution | Nationwide
Foreign: Germany,Japan, Singapore |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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