FDA Devices recall · Reported May 29, 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 diagnosis of diseases of the teeth.
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…
Chicago X-Ray Systems, Inc. recalled Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray s… - a moderate-severity action.
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray s… was recalled by Chicago X-Ray Systems, Inc. in May 29, 2013. Reason: The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 10…. Check the official notice for the remedy. Verify recall #Z-1179-2013 with the FDA Devices before acting.
The recall
Chicago X-Ray Systems, Inc. issued this moderate-severity FDA Devices recall-The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 10….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- May 29, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1179-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1179-2013 |
| Date reported | May 29, 2013 |
| Date initiated | July 3, 2012 |
| Recalling firm | Chicago X-Ray Systems, Inc. |
| Firm location | Prospect Heights, IL |
| Affected scope | 1960 units |
| Distribution | Worldwide Distribution- USA (nationwide) and Latin America. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1179-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026