Recall Z-0313-2026 ยท OAS X-Ray, Tomography, Computed, Dental
OSSTEM Implant Co., Ltd.
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
| Date | Nov 5, 2025 (initiated Aug 26, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information. |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183475 | T1-CS, T1-C Osstem Implant Co., Ltd., Aug 30, 2019 |