RegWardenFDA facility compliance records
Company

MEDTECH S.A.S

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2021: 1 recalls20171201812019120201202120222023202420252026
  • Recalls (4)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “MEDTECH S.A.S — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10034131-medtech-s-a-s/

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