Osstem recalls dental X-ray systems T2-C and T2-CS due to potential missing FDA certification label. Affected units may not meet safety standards. Contact for details.
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 T2-C and T2-CS because their labeling might not include a required FDA certification statement. This could mean the devices don't meet safety standards, though no injuries have been reported.
The device may lack a required FDA certification label that confirms it meets safety standards for radiological health. This omission could mean the device doesn't comply with U.S. regulations, but it does not cause immediate harm in normal use.
Dental professionals using Osstem Dental X-Ray System T2 models T2-C and T2-CS are likely affected. Patients using these systems may be at low risk if the device is properly labeled.
Check for product model numbers T2-C or T2-CS on the device. The UDI codes 08800000995601 and 08800000995618 are also associated with these units.
Look for the missing FDA certification statement on the device label.
No injuries have been reported, but the device may not meet safety standards due to missing labeling.
Check for model numbers T2-C or T2-CS or UDI codes 08800000995601 and 08800000995618.
Check the labeling for the missing certification statement. If it's missing, contact Osstem for guidance.
We’ve drafted a message you can send Osstem to request your refund or repair — edit it as you like.
Subject: Recall Z-0314-2026 — Osstem Osstem Hello, I own a Osstem that is covered by recall Z-0314-2026 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.
