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RVG 6200

CARESTREAM HEALTH, INC. · Model RVG 6200 · UDI-DI 60889978024384

EAP Prescription
10
510(k) clearances
592
Adverse events
6
Recalls
12
Facilities

Description

RVG 6100 #1 Operatory Kit

Recalls

DateFirmReason
2012-09-26DeGotzenIt was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
2012-09-18Trophy SasThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect tha
2012-09-18Trophy SasThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect tha
2012-09-18Trophy SasThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect tha
2012-09-18Trophy SasThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect tha
2012-07-03Chicago X-Ray Systems, Inc.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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.