Severity
Moderate
ModerateClass IITerminated
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…
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 FDA Devices action (record #Z-1179-2013) was formally reported on May 29, 2013, with the manufacturer initiating the action on July 3, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Chicago X-Ray Systems, Inc. is listed as the recalling firm, operating out of Prospect Heights, IL. Federal records list the affected scope as 1960 units.
The documented reason for this recall is: 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 C… Distribution data in the federal record shows the product reached: Worldwide Distribution- USA (nationwide) and Latin America.. Distribution scope 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 — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
1960 units
Related Recalls
6
6 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Chicago X-Ray Systems, Inc.. Units affected: 1960 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2013. Severity: Moderate. Recall number: Z-1179-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution- USA (nationwide) and Latin America..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1179-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 29, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).