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Chicago X-Ray Systems, Inc. recalls Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic e
Recalled May 29, 2013 · FDA recall Z-1179-2013 · Chicago X-Ray Systems
Hazard
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). · FDA Class II
Units
1960 units
Sold at
Worldwide Distribution- USA (nationwide) and Latin America.
Description
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).
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.
Manufacturer(s)
Chicago X-Ray Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →