FDA Device recall Z-0313-2026
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS by Osstem Implant, citing 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 St….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0313-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-26 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Osstem Implant |
| Distribution | n/a |
Product
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
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.
Identifiers
| code_info | UDI Codes: 08800000995793 and 08800000995526. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0313-2026%22
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