Trumpf Medical Systems, Inc. recalls Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions…

Recall date

December 15, 2017

Source

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

Recall number

Z-0824-2018

FDA classification

Class II

Brand / firm

Trumpf Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA. and to the countries of : Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Polan…

Why it was recalled

The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.

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

What was recalled

Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.