Recall Z-0824-2018 ยท FWB Camera, Television, Surgical, Without Audio
Trumpf Medical Systems, Inc.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
| Date | Dec 15, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| 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, Pol |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.