Carl Zeiss Meditec recalls Cirrus HD-OCT Model 6000 devices that were sold without proper pre-market clearance for high resolution tomographic imaging. Affected units have specific serial numbers listed in the recall notice.
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Carl Zeiss Meditec has recalled certain Cirrus HD-OCT Model 6000 devices because they were sold without proper pre-market clearance. This recall affects specific units with listed serial numbers and does not involve a safety hazard that could cause injury.
The devices were sold without obtaining necessary pre-market clearance from regulatory authorities before being commercialized. This means they were not approved for safety and effectiveness before being sold to medical professionals.
Ophthalmologists and medical professionals who use the Cirrus HD-OCT Model 6000 for eye imaging may own or use these devices. The risk is low as the issue is regulatory compliance, not a safety hazard.
Check for the specific serial numbers listed in the recall notice, which include a range of numbers starting with '6000-'. The product label shows 'CIRRUS HD-OCT Model 6000' with the material number '266002-1173-109/SD-OCT 6000 NEW CM ENH1' or '266002-1173-110/SD-OCT 6000 REFURB CM ENH1'.
Look for the serial numbers listed in the recall notice to determine if your device is affected.
The devices were sold without obtaining necessary pre-market clearance from regulatory authorities before being commercialized.
No, the recall is due to regulatory compliance issues, not a safety hazard that could cause injury.
Check the serial numbers on your device against the list provided in the recall notice, which includes specific numbers starting with '6000-'.
We’ve drafted a message you can send Carl Zeiss Meditec to request your refund or repair — edit it as you like.
Subject: Recall Z-2227-2021 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-2227-2021 from Carl Zeiss Meditec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
