General Electric Med Systems LLC

FDA Regulatory Profile

General Electric Med Systems LLC appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1788-2012, Class II) was initiated on May 31, 2006.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1788-2012Class IIGE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbMay 31, 2006
Z-1789-2012Class IIGE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , WMay 31, 2006
Z-1790-2012Class IIGE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259May 31, 2006