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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for regulatory non-compliance with no reported illnesses, injuries, or demonstrated safety defects. The hazard is theoretical (unverified safety/efficacy due to missing pre-market review) rather than a concrete defect, meeting the criteria for Moderate severity per the rubric.
Plain-English summary
Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging systems distributed across the United States, including Alaska, Hawaii, Guam, and Puerto Rico.
The recall is because the manufacturer failed to obtain pre-market FDA clearance before commercializing the device. Federal regulations require pre-market clearance for medical devices to verify safety and efficacy before sale.
No illnesses or injuries have been reported. Healthcare providers and patients who possess these devices should contact Carl Zeiss Meditec or the FDA for information about remediation options. Specific device serial numbers and material numbers are identified in the FDA recall notice.
The recalled product
- Product
- Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Category
- Medical Device — Imaging Device
- Affected units
- 914
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 6000-10008
- 6000-10010
- 6000-10011
- 6000-10012
- 6000-10015
- 6000-10016
- 6000-10017
- 6000-10020
- 6000-10021
- 6000-10022
- 6000-10023
- 6000-10024
- 6000-10025
- 6000-10026
- 6000-10029
- 6000-10031
- 6000-10032
- 6000-10034
- 6000-10038
- 6000-10039
Distribution
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