Recall Z-1184-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
| Date | Mar 8, 2019 |
| Status | Terminated |
| Reason | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Root cause | 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 blad |
| Quantity | 193 |
| Distribution | Nationwide Foreign: Germany,Japan, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) Gyrus Acmi, Inc., Apr 5, 2013 |