Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is Recalled by Chicago X-Ray Systems, Inc. Due to The IntraOs 70 system was found to have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Chicago X-Ray Systems, Inc. directly.
Affected Products
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.
Quantity: 1960 units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Chicago X-Ray Systems, Inc.
Chicago X-Ray Systems, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report