Fujifilm Medical System USA, Inc.

FDA Regulatory Profile

Fujifilm Medical System USA, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1642-2014, Class II) was initiated on June 29, 2012.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1642-2014Class IIMXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generatorJune 29, 2012