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Recall Observatory FDA recall evidence

Device product

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.

Z-0391-2017

October 25, 2016

Class II

Product summary

Firm
Trumpf Medical Systems, Inc.
Event
Event 75412
Status
Terminated
Classification
Class II
Quantity
4 (US) & 229 (Foreign)
Official record key
device-enforcement:Z-0391-2017

Official wording

Reason: Trumpf has identified six incidents of pinched cables.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Trumpf has identified six incidents of pinched cables.