United StatesOsstem Dental X‑Ray Systems T1 (models T1‑C, T1‑CS), T2 (T2‑C, T2‑CS), and T2Plus (T2‑C‑P, T2‑CS‑P) are affected; UDI codes include 08800000995793, 08800000995526, 08800000995601, 08800000995618, 08800000996059, and 08800000996042. The recall was initiated because the product labeling may be missing the required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). No further actions for owners are specified in the notice.
What's being recalled
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Recalling firm: OSSTEM Implant Co., Ltd., Haeundae District, N/A, Korea (the Republic of).
How to identify it
UDI Codes: 08800000995793 and 08800000995526. UDI Codes: 08800000995601 and 08800000995618. UDI Codes: 08800000996059 and 08800000996042.
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)