FDA-Device2022-09-21Class II
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Mako Surgical Corporation
Hazard
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
Sold states
US Distribution was made to IL and AZ.
Affected count
2
Manufactured in
3365 Enterprise Ave, Weston, FL, United States
Products
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2022Don't want to check this manually?
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