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U.S. Department of Health and Human Services

Class 2 Device Recall FONA Blue X Imaging Srl

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  Class 2 Device Recall FONA Blue X Imaging Srl see related information
Date Initiated by Firm July 03, 2012
Date Posted May 21, 2013
Recall Status1 Terminated 3 on September 05, 2017
Recall Number Z-1179-2013
Recall Event ID 65018
Product Classification Unit, x-ray, intraoral - Product Code EAP
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.
Code Information Model IntraOs 70
Recalling Firm/
Manufacturer		 Chicago X-Ray Systems, Inc.
65 E Palatine Rd Ste 121
Prospect Heights IL 60070-1845
For Additional Information Contact Al Sosa
847-459-3889
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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