Recall Z-1179-2013 ยท EAP Unit, X-Ray, Intraoral
Chicago X-Ray Systems, Inc.
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.
| Date | May 21, 2013 (initiated Jul 3, 2012) |
| Status | Terminated |
| 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | FONA will have upgraded copies of the manuals that will be made available on the firms website for free download and may also be mailed to each customer or end user should they request it. They will also provide users and distributers with corrected system labels to be placed on the x-ray control, beam limiting device, and tube housing assembly along with instructions for the proper application of these labels. They will provide users and distributers with an amended "Technical Data" page for insertion int the user's manual. Further questions please call (847) 459-3889. |
| Quantity | 1960 units |
| Distribution | Worldwide Distribution- USA (nationwide) and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.