Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-1103-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 13, 2022

Date Posted: February 15, 2023

Recall Number: Z-1103-2023

Event ID: 91291

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

Status: Ongoing

Product Quantity: 13 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated