Recall – Surgical system may inadvertently permit RF energy release

Company: Gyrus ACMI, Inc.
Date of Enforcement Report: 4/24/2019
Class II:

PRODUCT

Olympus Diego Elite Console MDCONS 100; Recall Number: Z-1178-2019

Part No BB2000SA; Recall Number: Z-1179-2019

Part Number: BB4000SS; Recall Number: Z-1180-2019

Part No: BB4000SC; Recall Number: Z-1181-2019

Product Number:BB4040SS; Recall Number: Z-1182-2019

Product Number: BB4040SC; Recall Number: Z-1183-2019

Product Number: BB4040XS; Recall Number: Z-1184-2019

Product Number: BB4040XC; Recall Number: Z-1185-2019

Product Code:MB4000SS; Recall Number: Z-1186-2019

Product Code:MM4000SS; Recall Number: Z-1187-2019

 

REASON

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

RECALLING FIRM/MANUFACTURER

Gyrus ACMI, Inc. on 3/8/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
US: 107 consoles, OUS: 157 consoles

DISTRIBUTION

US Nationwide and International

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