Trumpf Medical Systems, Inc. recalls Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia i…

Recall date

July 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0041-2017

FDA classification

Class II

Brand / firm

Trumpf Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stationary Column TruSystem 7599, Material Number 1717020 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.