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Recall Observatory FDA recall evidence

Device product

TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

Z-0141-2015

October 09, 2014

Class II

Product summary

Firm
Trumpf Medical Systems, Inc.
Event
Event 69426
Status
Terminated
Classification
Class II
Quantity
184 units
Official record key
device-enforcement:Z-0141-2015

Official wording

Reason: Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.

Code information: TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.

Distribution pattern: Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.