FDA Medical Device Recalls (openFDA)
Gyrus ACMI, Inc.: Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Recall number
- Z-1182-2019
- Recalling firm
- Gyrus ACMI, Inc.
- Product
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Status
- Terminated
- Initiated
- 2019-03-08
- Posted
- not on file
- Terminated
- 2020-05-08
- 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 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
- 247
- Distribution
- Nationwide Foreign: Germany,Japan, Singapore
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- ["K123429"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1037007
- Firm city
- Bartlett
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28