Fujifilm Medical System USA MXR-35 Diagnostic X-ray High Voltage Generator manufactured by recall — FDA Z-1642-2014
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Overview of recall records associated with Fujifilm Medical System USA, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
This page summarizes recall records in which the official source identifies Fujifilm Medical System USA, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.