Z-1184-2019Class II

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS

Name: Z-1184-2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Creator: Gyrus ACMI, Inc.
Published: 2019-03-08
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2019-03-08 / Terminated / root cause: software

FDA source

Gyrus ACMI, Inc. began a recall of Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS on 2019-03-08. FDA classified it as Class II and gives the reason as "Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1184-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-08
Posted: 2019-04-17
Terminated: 2020-05-08
Recalling firm: Gyrus ACMI, Inc.
Product: Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Root cause tag: software
FDA 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 in commerce: 193
Distribution: Nationwide Foreign: Germany,Japan, Singapore
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1178-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1179-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1180-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1181-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1182-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1183-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1184-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1185-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1186-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1187-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17

Product code GEI

K123429Class IIOlympus Energy Power System (Eps)Gyrus Acmi, Inc. / cleared 2013-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)