Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
- Company
- Gyrus Acmi, Inc.
- Recall Initiated
- March 8, 2019
- Terminated
- May 8, 2020
- Recall Number
- Z-1186-2019
- Quantity
- 318
- Firm Location
- Bartlett, TN
Reason for Recall
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Distribution
Nationwide Foreign: Germany,Japan, Singapore
Lot / Code Info
All lot numbers
Root Cause
Software design
Action Taken
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.