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Chicago X-Ray Systems Recalls

1 recall on record · May 29, 2013 to May 29, 2013 · Medical Devices

May 29, 2013Medical DevicesFDA

Chicago X-Ray Systems, Inc. recalls Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic e

Hazard: 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).

Chicago X-Ray Systems Recalls | RecallWatchUSA