Home / Recalls / Chicago X-Ray Systems, Inc. / Z-1179-2013

Z-1179-2013 Class II Terminated

Recalled by Chicago X-Ray Systems, Inc. — Prospect Heights, IL

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