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RVG 6100
CARESTREAM HEALTH, INC. · Model RVG 6100 · UDI-DI 60889975314167
EAP
Prescription
10
510(k) clearances
592
Adverse events
6
Recalls
12
Facilities
Description
RVG 6100 - SIZE 0 w/o USB HUB
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-09-26 | DeGotzen | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification |
| 2012-09-18 | Trophy Sas | There 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 |
| 2012-09-18 | Trophy Sas | There 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 |
| 2012-09-18 | Trophy Sas | There 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 |
| 2012-09-18 | Trophy Sas | There 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 |
| 2012-07-03 | Chicago 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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Get your free API keyRead the docsData 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.