Home / Recalls / Trumpf Medical Systems, Inc. / Z-0563-2016

Z-0563-2016 Class II

Recalled by Trumpf Medical Systems, Inc. — Charleston, SC

Recall Details

Product Type
Devices
Report Date
January 6, 2016
Initiation Date
November 2, 2015
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,713

Product Description

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

Reason for Recall

The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.

Distribution Pattern

USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.

Code Information

4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)

Other recalls by Trumpf Medical Systems, Inc.

  • Z-0824-2018 Class II — Camera System, Television, Surgical without audio Intended for transmission a (December 15, 2017)
  • Z-0391-2017 Class II — OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; (October 25, 2016)
  • Z-0040-2017 Class II — Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5 (July 10, 2016)
  • Z-0042-2017 Class II — Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column (July 10, 2016)
  • Z-0041-2017 Class II — Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning (July 10, 2016)
  • Z-0043-2017 Class II — Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSy (July 10, 2016)
  • Z-0759-2016 Class II — Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, (January 19, 2016)
  • Z-2353-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. (July 27, 2015)
  • Z-2356-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #14001 (July 27, 2015)
  • Z-2355-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manua (July 27, 2015)