Recall Z-1181-2019— Gyrus ACMI, Inc.

Name: FDA recall Z-1181-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-08

Class II · Terminated

Class II FDA medical device recall by Gyrus ACMI, Inc., initiated 2019-03-08, terminated 2020-05-08. It names one FDA 510(k) clearance: K123429. Product: Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC. Reason: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades.

Recalling firm: Gyrus ACMI, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-08
Terminated: 2020-05-08
Firm location: Bartlett, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123429 — OLYMPUS ENERGY POWER SYSTEM (EPS)Gyrus Acmi, Inc.·cleared 2013-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.