Z-1179-2013 Class II Terminated
FDA device recall Z-1179-2013 was initiated by Chicago X-Ray Systems, Inc. on July 3, 2012 and is designated Class II. 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 … The recall status is terminated (terminated September 5, 2017). Affected quantity: 1960 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- July 3, 2012
- Termination Date
- September 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1960 units
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).
Distribution Pattern
Worldwide Distribution- USA (nationwide) and Latin America.
Code Information
Model IntraOs 70