FDA recall Z-0824-2018

Trumpf Medical Systems, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2017-12-15
Report date
2018-03-07
Termination date
2020-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charleston, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0824-2018