FDAClass IIMarch 7, 2018

Camera System recall

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

Why was Camera System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving…
Recalling firm
Trumpf Medical Systems, Inc.
Quantity
212 devices
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.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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