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FDADecember 13, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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