Reported May 29, 2013 · Terminated
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic…
Chicago X-Ray Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Chicago X-Ray Systems, Inc. · 65 E Palatine Rd Ste 121 · Prospect Heights, IL · 60070-1845
Is this the product you have?
- 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.
- Lot codes and dates
- Model IntraOs 70
- Amount recalled
- 1960 units
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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