Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0824-2018 · Posted None

Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeFWB
Date Initiated2017-12-15
Date Terminated2020-04-23
Product Quantity212 devices

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.

Firm 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

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑