Osstem recalls dental X-ray systems T1-C and T1-CS due to missing required FDA certification label. This may affect compliance with radiological health regulations.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
Osstem is recalling dental X-ray systems T1-C and T1-CS because their labeling might not include a required FDA certification statement. This could mean the devices don't meet safety standards for radiological health regulations.
The device may lack a required certification statement that confirms compliance with FDA radiological health regulations. This omission could mean the device doesn't meet safety standards for medical use, but it doesn't pose an immediate physical risk during normal operation.
Dental clinics and healthcare providers using Osstem Dental X-Ray System T1 models T1-C and T1-CS are most at risk. The recall affects devices sold with specific UDI codes.
Check for product model numbers T1-C or T1-CS on the device. The recall includes devices with UDI codes 08800000995793 and 08800000995526.
Look for the missing certification statement on the device label.
The recall is for missing a required FDA certification statement that confirms compliance with radiological health regulations.
The Osstem Dental X-Ray System T1 models T1-C and T1-CS with UDI codes 08800000995793 and 08800000995526.
No, but you should check for the missing certification statement as the recall is for labeling compliance, not immediate safety risks.
We’ve drafted a message you can send Osstem to request your refund or repair — edit it as you like.
Subject: Recall Z-0313-2026 — Osstem Osstem Hello, I own a Osstem that is covered by recall Z-0313-2026 from Osstem. 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.
