Med Tec Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2243-2020Class IIType S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended fMay 12, 2020
Z-1837-2019Class IICIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: TheApril 15, 2019
Z-0671-2018Class IIProtura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, November 8, 2017
Z-3082-2017Class IICIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 1060August 10, 2017
Z-3083-2017Class IICIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) August 10, 2017
Z-1992-2016Class IIProtura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number March 31, 2016
Z-2763-2015Class IICIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. August 19, 2015
Z-0989-2015Class IICivco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wDecember 11, 2014
Z-0990-2015Class IICivco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nyloDecember 11, 2014