Recall Z-1180-2019
Gyrus ACMI, Inc. · initiated March 8, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Codes / lots: All lot numbers
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: 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.
Details
- Recall number
- Z-1180-2019
- Initiated
- March 8, 2019
- Terminated
- May 8, 2020
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 1333
- Distribution
- Nationwide Foreign: Germany,Japan, Singapore
- Recalling firm
- Gyrus ACMI, Inc., Bartlett, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1178-2019 Class II | Olympus Diego Elite Console MDCONS 100Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1179-2019 Class II | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No…Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1181-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1182-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1183-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1184-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1185-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1186-2019 Class II | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1187-2019 Class II | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |