Recall Z-1178-2019
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
Olympus Diego Elite Console MDCONS 100
Codes / lots: Consoles containing software UIC version 2.3.9.0 and RTC version 00.01.23 US Serial Numbers: GB00197 GB02851 GB04383 GB00235 GB02878 GB04384 GB00238 GB02995 GB04386 GB00270 GB03000 GB04400 GB00278 GB03054 GB04401 GB00280 GB03171 GB04412 GB00870 GB03173 GB04414 GB00886 GB03201 GB04416 GB00917 GB03232 GB04417 GB00925 GB03431 GB04419 GB00937O GB03519 GB04420 GB00949 GB03675 GB04481 GB02173 GB03714 GB04482 GB02250 GB03717 GB04483 GB02263 GB03733 GB04484 GB02268 GB03746 GB04485 GB02289 GB03782 GB04486 GB02366 GB03790 GB04488 GB02368 GB03791 GB04489 GB02372 GB03793 GB04490 GB02381 GB03923 GB04491 GB02390 GB03941 GB04496 GB02406 GB03961 GB04497 GB02422 GB03966 GB04498 GB02442 GB04008 GB04503 GB02446 GB04022 GB04506 GB02453 GB04035 GB04507 GB02457 GB04041 GB04515 GB02507 GB04195 GB04516 GB02538 GB04212 GB04517 GB02539 GB04214 GB04534 GB02602 GB04241 GB04540 GB02613 GB04243 GB04592 GB02716 GB04246 GB02807 GB04315 GB02808 GB04338 GB04367 OUS: GB03672 GB02338 GB02414 GB02863 GB00205 GB02324 GB02719 GB02933 GB02955 GB03799 GB02172 GB02460 GB02204 GB00857 GB00907 GB02928 GB00876 GB02413 GB00850 GB00879 GB00852 GB02466 GB02584 GB00698 GB02580 GB00904 GB02924 GB02930 GB00844 GB03946 GB03747…
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-1178-2019
- Initiated
- March 8, 2019
- Terminated
- May 8, 2020
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- US: 107 consoles, OUS: 157 consoles
- Distribution
- Nationwide Foreign: Germany,Japan, Singapore
- Recalling firm
- Gyrus ACMI, Inc., Bartlett, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-1180-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SSOlympus 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 |