Home / Recalls / Trumpf Medical Systems, Inc. / Z-0391-2017

Z-0391-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 16, 2016
Initiation Date
October 25, 2016
Termination Date
February 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 (US) & 229 (Foreign)

Product Description

OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.

Reason for Recall

Trumpf has identified six incidents of pinched cables.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland

Code Information

Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656

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-0040-2017 Class II — Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5 (July 10, 2016)
  • Z-0043-2017 Class II — Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSy (July 10, 2016)
  • Z-0041-2017 Class II — Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning (July 10, 2016)
  • Z-0042-2017 Class II — Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column (July 10, 2016)
  • Z-0759-2016 Class II — Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, (January 19, 2016)
  • Z-0563-2016 Class II — Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Sur (November 2, 2015)
  • Z-2354-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual (July 27, 2015)
  • Z-2353-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. (July 27, 2015)
  • Z-2355-2015 Class II — Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manua (July 27, 2015)