T2 dental X-ray systems recalled over an omitted certification statement
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 as a documentation issue: the record cites an omitted certification statement on the labeling, with no device defect or reported harm.
Plain-English summary
The Osstem Dental X-Ray System T2, product models T2-C and T2-CS, is the subject of a voluntary medical device correction.
Osstem Implant states the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations), specifically the statement that the product complies with all applicable performance standards.
The correction covers products carrying UDI codes 08800000995601 and 08800000995618, distributed in the United States. The FDA has classified the action as Class II.
The enforcement record describes a missing labeling statement rather than a device defect, and reports no injuries. Sites operating an affected system should follow the firm's instructions.
The recalled product
- Product
- Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Manufacturer
- OSSTEM Implant Co., Ltd.
- Category
- Medical Device — Dental imaging
- Hazard
- missing-certification-statement
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI Codes: 08800000995601 and 08800000995618.
Distribution
Distribution scope not specified by the agency.
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