MedTech-LLC

4 recall(s) on record — most severe on record: Class I.

Registered facilities (1)

• MEDTECH LLC FEI 3010123256 · TN

Recalls & enforcement

• Class IOngoing2021-09-22
  The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or
• Class IITerminated2020-01-06
  Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
• Class ITerminated2019-09-10
  The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
• Class IITerminated2018-05-08
  Replacement of units lacking an updated device approval.