FDA Device recall Z-1179-2013
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnos…
- FDA Device
- Class II
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class II recall of Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnos… by Chicago X Ray Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1179-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-03 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Chicago X Ray Systems |
| Distribution | US |
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
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).
Identifiers
| code_info | Model IntraOs 70 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2013%22
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