Home / Recalls / Olympus Corporation of the Americas / Z-1103-2023

Z-1103-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
February 15, 2023
Initiation Date
December 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product Description

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

Reason for Recall

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

Distribution Pattern

FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA

Code Information

UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412

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