Carl Zeiss Meditec recalls specific Zeiss Intrabeam Spherical Applicators due to failing to meet manufacturing specifications. Affected units include certain serial numbers and batch numbers. Consumers should contact the manufacturer for details.
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Carl Zeiss Meditec is recalling specific models of their 1.5 cm Spherical Applicators used in radiation therapy. The recall is because these devices did not meet required manufacturing standards, which could lead to improper function during medical procedures.
The spherical applicators failed to meet manufacturing specifications, meaning they might not function correctly during radiation therapy procedures. This could result in improper treatment delivery or other complications.
Medical professionals using radiation therapy equipment are most likely affected. Patients receiving treatment with these applicators may also be impacted if the device fails.
Check for the serial numbers: US - A63141, A63086 or OUS - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313. Also look for batch number A0002 and reference number REF:304534-6000-557.
Reach out to Carl Zeiss Meditec for specific instructions on how to return or replace the affected device.
The Zeiss Intrabeam Spherical Applicators failed to meet manufacturing specifications, which could lead to improper function during radiation therapy.
Contact Carl Zeiss Meditec directly for details on returning or replacing the affected device.
Yes, affected units include US serial numbers A63141 and A63086, and OUS serial numbers A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313.
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-2649-2026 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-2649-2026 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.