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Trumpf Medical Systems, Inc. recalls Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventio
Recalled March 7, 2018 · FDA recall Z-0824-2018 · Trumpf Medical Systems
Hazard
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. · FDA Class II
Units
212 devices
Sold at
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, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.
Description
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.
Product
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
Manufacturer(s)
Trumpf Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →