Olympus Diego Elite Console MDCONS 100
Medical device recall Z-1178-2019. Published in FDA’s Enforcement Report on Apr 24, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 24, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- US: 107 consoles, OUS: 157 consoles how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Olympus Diego Elite Console MDCONS 100
US: 107 consoles, OUS: 157 consoles, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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 GB03226 GB03550 GB02940 GB02582 GB03432 GB04013 GB00959 GB03983 GB02655 GB02694 GB02576 GB02704 GB02925 GB02193 GB02216 GB00180 GB04244 GB00206 GB00266 GB00837 GB02463 GB00267 GB00848 GB00873 GB00821 GB03007 GB02558 GB00822 GB03233 GB02480 GB02569 GB02833 GB02559 GB02563 GB02557 GB00833 GB00702 GB02560 GB02656 GB02658 GB03005 GB02565 GB02500 GB02573 GB03677 GB02561 GB04204 GB03819 GB03921 GB02805 GB02282 GB02594 GB03189 GB02593 GB03716 GB04023 GB02659 GB02861 GB00700 GB03043 GB02283 GB03045 GB02568 GB00830 GB02889 GB03162 GB02567 GB02511 GB03023 GB03530 GB02304 GB02461 GB02519 GB02465 GB02415 GB02308 GB02328 GB02518 GB02325 GB02313 GB02494 GB04347 GB00897 GB02336 GB02579 GB00919 GB02196 GB00964 GB02194 GB00269 GB00899 GB00969 GB02280 GB02443 GB02864 GB03522 GB02217 GB03984 GB03207 GB00854…
FDA’s list runs to 2,202 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: Germany,Japan, Singapore
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 8, 2019.
- FDA classified it on Apr 17, 2019.
- FDA’s Enforcement Report published it on Apr 24, 2019.
- FDA terminated it on May 8, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Gyrus ACMI, Inc., of Bartlett, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,202 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.