Forte Automation Systems Inc

FDA Regulatory Profile

Forte Automation Systems Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2537-2018, Class II) was initiated on September 5, 2017. Its most recent 510(k) clearance was granted on April 13, 2017.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2537-2018Class IIPatient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product UsSeptember 5, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K170502Patient Positioning SystemApril 13, 2017
K122413PATIENT POSITIONING SYSTEMSeptember 13, 2012