Recall Z-1179-2013— Chicago X-Ray Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Chicago X-Ray Systems, Inc., initiated 2012-07-03, terminated 2017-09-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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)..
- Recalling firm
- Chicago X-Ray Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-03
- Terminated
- 2017-09-05
- Firm location
- Prospect Heights, IL, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.