Trumpf Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
31
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0824-2018Class IICamera System, Television, Surgical without audio Intended for transmission and documentation of December 15, 2017
Z-0391-2017Class IIOR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H October 25, 2016
Z-0041-2017Class IIStationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranJuly 10, 2016
Z-0042-2017Class IIFloor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material NumbJuly 10, 2016
Z-0040-2017Class IIMobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material NumberJuly 10, 2016
Z-0043-2017Class IIOperating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), MJuly 10, 2016
Z-0759-2016Class IIPatient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSysJanuary 19, 2016
Z-0563-2016Class IICeiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iNovember 2, 2015
Z-2357-2015Class IITrumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF suJuly 27, 2015
Z-2353-2015Class IITrumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgiJuly 27, 2015
Z-2355-2015Class IITrumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TJuly 27, 2015
Z-2354-2015Class IITrumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRJuly 27, 2015
Z-2356-2015Class IITrumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF suJuly 27, 2015
Z-0919-2015Class IICable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. PaDecember 3, 2014
Z-0928-2015Class IICable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. PatientDecember 3, 2014
Z-0918-2015Class IICable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient pDecember 3, 2014
Z-0922-2015Class IIIR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. PatieDecember 3, 2014
Z-0923-2015Class IIIIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positDecember 3, 2014
Z-0925-2015Class II(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient December 3, 2014
Z-0929-2015Class IIIR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient poDecember 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K011693TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001June 13, 2001