FDAFDA · Food and drugs·Recall number Z-1179-2013
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.
Published May 29, 2013 · Recall initiated: July 3, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Chicago X-Ray Systems, Inc.
- Distributor
- Worldwide Distribution- USA (nationwide) and Latin America.
- Lot
- Model IntraOs 70
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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