Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra… — Class II medical device recall Z-1179-2013
Terminated recall by Chicago X-Ray Systems, Inc., reported 2013-05-29, distributed nationwide. The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 101
| Recall number | Z-1179-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chicago X-Ray Systems, Inc., Prospect Heights, IL, United States |
| Recall initiated | 2012-07-03 |
| Classified | 2013-05-21 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,960 units |
| Reason classes | labeling |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1179-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.