Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1179-2013 · Posted 2013-05-21

Recalling FirmChicago X-Ray Systems, Inc.
Recall StatusTerminated
Product CodeEAP
Date Initiated2012-07-03
Date Terminated2017-09-05
Product Quantity1960 units

Reason for Recall

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).

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution- USA (nationwide) and Latin America.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑