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Olympus Corporation of the Americas recalls SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Recalled February 15, 2023 · FDA recall Z-1103-2023 · Olympus Corporation of the Americas
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 · FDA Class II
Units
13 units
Sold at
FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Description
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
Product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →