CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance
Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.
- Product
- Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
- Category
- Medical Device
- Distribution
- 53 states