Device recall: Olympus Diego Elite Console MDCONS 100
Class II FDA enforcement event 82451. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Class II, in the words of FDA
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
Gyrus ACMI, Inc. started this device recall on 8 Mar 2019. The firm address in the FDA record is in Bartlett, TN. FDA put the recall in Class II. FDA event 82451 has 10 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 8 May 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign: Germany,Japan, Singapore
Recalling firm
Gyrus ACMI, Inc., Bartlett, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1178-2019 | Olympus Diego Elite Console MDCONS 100 | US: 107 consoles, OUS: 157 consoles | Class II | Terminated | 24 Apr 2019 |
| Z-1179-2019 | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA | 502 OUS | Class II | Terminated | 24 Apr 2019 |
| Z-1180-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS | 1333 | Class II | Terminated | 24 Apr 2019 |
| Z-1181-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC | 82 | Class II | Terminated | 24 Apr 2019 |
| Z-1182-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS | 247 | Class II | Terminated | 24 Apr 2019 |
| Z-1183-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC | 13 | Class II | Terminated | 24 Apr 2019 |
| Z-1184-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS | 193 | Class II | Terminated | 24 Apr 2019 |
| Z-1185-2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC | 21 | Class II | Terminated | 24 Apr 2019 |
| Z-1186-2019 | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS | 318 | Class II | Terminated | 24 Apr 2019 |
| Z-1187-2019 | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS | 161 | Class II | Terminated | 24 Apr 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 10Median of the firm: 10
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Aug 2017 | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system Event 79548 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1178-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82451. https://recallregister.com/fda/ii/82451/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign: Germany,Japan, Singapore
- What quantity of product is in FDA event 82451?
- The event has 10 product records. The first record gives this quantity:
US: 107 consoles, OUS: 157 consoles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.