FDA Medical Device Recalls (openFDA)
Chicago X-Ray Systems, Inc.: 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.
- Recall number
- Z-1179-2013
- 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.
- Status
- Terminated
- Initiated
- 2012-07-03
- Posted
- 2013-05-21
- Terminated
- 2017-09-05
- Reason
- 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
- 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
- 1960 units
- Distribution
- Worldwide Distribution- USA (nationwide) and Latin America.
- Lot, serial or model codes
- Model IntraOs 70
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EAP
- Firm FEI
- 1000115053
- Firm city
- Prospect Heights
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28