FDA-Device2016-10-12Class II

Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

Trumpf Medical Systems, Inc.
Hazard

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Sold states
Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
Affected count
84 units
Manufactured in
1046 Legrand Blvd, N/A, Charleston, SC, United States
Products
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2017

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