Carl Zeiss Meditec recalls CIRRUS HD-OCT models 5000 AngioPlex and 6000 AngioPlex with unapproved optic nerve head angiography scans. Affected units have specific software versions and serial numbers.
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Carl Zeiss Meditec is recalling two models of OCT scanners because they include an unapproved optic nerve head angiography scan feature. This could pose a risk if the scan is turned on without proper regulatory approval.
The device includes an optic nerve head angiography scan feature that was distributed without pre-market regulatory approval. This means the scan could be used in a way that is not approved for safety or effectiveness.
Ophthalmologists and medical professionals using the CIRRUS HD-OCT models 5000 AngioPlex and 6000 AngioPlex are most at risk. The recall affects specific software versions and serial numbers.
Check if your CIRRUS HD-OCT has serial numbers with software versions 11.5, 11.5.1, or 11.5.2 and the ONH Angiography 4.5x4.5mm Scan feature.
Verify your device's software version is 11.5, 11.5.1, or 11.5.2.
The CIRRUS HD-OCT models include an optic nerve head angiography scan feature distributed without pre-market regulatory approval.
The recall record does not specify a remedy, so no action is required beyond checking your software version.
Software versions 11.5, 11.5.1, and 11.5.2.
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-0723-2022 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-0723-2022 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.
