Recall Z-1103-2023— Olympus Corporation of the Americas

Name: FDA recall Z-1103-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-13

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-12-13. It names one FDA 510(k) clearance: K170023. Product: SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D). Reason: 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.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-12-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K170023 — SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.·cleared 2017-05-15

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

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

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