Recall Z-0824-2018— Trumpf Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2017-12-15, terminated 2020-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.. 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..
- Recalling firm
- Trumpf Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-15
- Terminated
- 2020-04-23
- Firm location
- Charleston, SC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.