Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
- Company
- Trumpf Medical Systems, Inc.
- Recall Initiated
- December 15, 2017
- Terminated
- April 23, 2020
- Recall Number
- Z-0824-2018
- Quantity
- 212 devices
- Firm Location
- Charleston, SC
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.
Lot / Code Info
Catalog Number 1940747, All serial numbers: 102584474, 102584475, 102584477, 102584478, 102805330, 102813656, 102813657, 102813658, 102813659, 102813660, 102813661, 102813662, 102860647, 102860652, 102863706, 102863707, 102867783, 102867784, 102925734, 102925735, 102925736, 102925737, 102925738, 102925739, 102925740, 102925741, 102925742, 102925743, 102928703, 102932185, 102932186, 102932187, 102932188, 102932189, 102932203, 102932204, 102932205, 102932206, 102932207, 102932208, 102932209, 102932210, 102932211, 102932212, 102932217, 102932218, 102932219, 102932220, 102932221, 102932223, 102934525, 102934526, 102934527, 102934528, 102934529, 102936117, 102939484, 102940382, 102940383, 102940384, 102940386, 102940387, 102940388, 102940389, 102940390, 102940391, 102940408, 102940409, 102940410, 102961390, 102961391, 102961392, 102961393, 102961394, 102961395, 102961396, 102961397, 102961398, 102961399, 102961400, 102961401, 102975336, 102986494, 102986495, 102988480, 102989096, 102989607, 102989608, 102989615, 102990285, 102990286, 102994502, 102994503, 102994504, 102994505, 102994506, 102994525, 102994526, 102994529, 102994530, 102996306, 103005879, 103005880, 103005889, 103005890, 103005891, 103005892, 103005893, 103006636, 103010023, 103010759, 103010760, 103010761, 103010762, 103010763, 103012786, 103012787, 103013644, 103017040, 103017041, 103019900, 103020713, 103022348, 103022349, 103022350, 103022351, 103022352, 103022794, 103024049, 103024050, 103030284, 103031623, 103034106, 103034109, 103038842, 103038843, 103038844, 103038845, 103038846, 103038847, 103038848, 103038849, 103038850, 103038853, 103038854, 103038855, 103038856, 103038857, 103038858, 103038859, 103038860, 103038861, 103038862, 103038863, 103038864, 103038865, 103038866, 103039468, 103042319, 103042320, 103042321, 103042322, 103042925, 103042926, 103046119, 103046120, 103046121, 103046122, 103046123, 103046124, 103046125, 103046126, 103046127, 103046128, 103046129, 103046130, 103048248, 103065061, 103070795, 103070796, 103070797, 103070798, 103079001, 103079053, 103087365, 103087366, 103087367, 103087368, 103087369, 103087370, 103087371, 103090135, 103090136, 103090137, 103091507, 103091508, 103091509, 103091510, 103091511, 103095664, 103101676, 103101826, 103101864, 103101886, 103103841, 103103842, 103103843, 103103844, 103103845, 103104556, 103113059, 103117961, 103118986, 103118987, 103118988, 103118989, 103118990, 103118991, 103118992, 103118993, 103118994, 103118995, 103123759, 103133224, 103134656, 103138822, 103143214, 103149993, 103164298, 103168053, 103168341, 103168431, 103176559, 103176571, 103176574, 103191728, 103191729, 103194419, 103214005, 103214022.
Root Cause
Other
Action Taken
Trumpf Medical Systems sent an Urgent Medical Device Correction letter dated December 15, 2017. Instructions include to complete and return the Confirmation of Receipt, arrange for the Trumpf Medical Engineer or an authorized Service Engineer to upgrade the affected device, and ensure that all users of the device are aware of the recall. For further questions, please call (843) 329-0543