Recall Z-3311-2018— Olympus Corporation of the Americas

Name: FDA recall Z-3311-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2018-08-08, terminated 2022-05-17. It names one FDA 510(k) clearance: K082720. Product: Airway Mobilescope MAF-TM. Reason: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Terminated: 2022-05-17
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K082720 — TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005Olympus Medical Systems Corporation·cleared 2008-11-05

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

Airway Mobilescope MAF-TM

Reason for recall

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

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