Reported Apr 24, 2019 · Terminated

Olympus Diego Elite Console MDCONS 100

Gyrus ACMI, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gyrus ACMI, Inc. · 2925 Appling Rd · Bartlett, TN · 38133-3901

Is this the product you have?

  • Olympus Diego Elite Console MDCONS 100
Lot codes and dates
  • Consoles containing software UIC version 2.3.9.0 and RTC version 00.01.23
  • US Serial Numbers

    102 of 102 codes

    • 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
  • GB04315 GB02808 GB04338 GB04367 OUS

    157 of 157 codes

    • 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
Amount recalled
US: 107 consoles, OUS: 157 consoles

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

  • Nationwide

Why it was recalled

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2020 · Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.