Device product
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Z-1179-2013
Product summary
- Event
- Event 65018
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1960 units
- Official record key
device-enforcement:Z-1179-2013
Official wording
Reason: The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
Code information: Model IntraOs 70
Distribution pattern: Worldwide Distribution- USA (nationwide) and Latin America.
Derived failure modes
-
Unknown
The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).