Z-0824-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- December 15, 2017
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212 devices
Product Description
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 Pattern
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.
Code Information
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.