Z-1179-2013Class II

Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental...

Name: Z-1179-2013 Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental...
Creator: Chicago X-Ray Systems, Inc.
Published: 2012-07-03
License: https://open.fda.gov/license/

Chicago X-Ray Systems, Inc. / initiated 2012-07-03 / Terminated / root cause: labeling and UDI

FDA source

Chicago X-Ray Systems, Inc. began a recall of 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... on 2012-07-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1179-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Posted: 2013-05-21
Terminated: 2017-09-05
Recalling firm: Chicago X-Ray Systems, Inc.
Product: 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 code: EAP Unit, X-Ray, Intraoral
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).
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: FONA will have upgraded copies of the manuals that will be made available on the firms website for free download and may also be mailed to each customer or end user should they request it. They will also provide users and distributers with corrected system labels to be placed on the x-ray control, beam limiting device, and tube housing assembly along with instructions for the proper application of these labels. They will provide users and distributers with an amended "Technical Data" page for insertion int the user's manual. Further questions please call (847) 459-3889.
Quantity in commerce: 1960 units
Distribution: Worldwide Distribution- USA (nationwide) and Latin America.
Product codes and lots: Model IntraOs 70

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1179-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-21

Product code EAP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)