Chicago X-Ray Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1179-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 3, 2012

Date Posted: May 29, 2013

Recall Number: Z-1179-2013

Event ID: 65018

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).

Status: Terminated

Product Quantity: 1960 units

Code Information:

Model IntraOs 70

Distribution Pattern:

Worldwide Distribution- USA (nationwide) and Latin America.

Voluntary or Mandated:

Voluntary: Firm initiated