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Medtech SAS

Country not established FDA FEI 3009185973

Devices
0
Registrations
FDA
FDA recalls
51 ongoing

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Company details

FDA FEI number
3009185973
Address
432 rue du Rajol, MAUGUIO Occitanie

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 1
  • 2020 2
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 22 Sep 2021 Z-0118-2022 Class I Ongoing 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 death if undetected during surgery. Distribution: US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan,…
      Full distribution text US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
      Submission numbers: K182417, K200511

  • 2020

    • 6 Jan 2020 Z-1150-2020 Class II Terminated 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. Distribution: US Nationwide Submission numbers: K172444, K151359, K182417
    • 6 Jan 2020 Z-1151-2020 Class II Terminated 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. Distribution: US Nationwide Submission numbers: K172444, K151359, K182417

  • 2019

    • 10 Sep 2019 Z-0172-2020 Class I Terminated 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. Distribution: Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam. Submission numbers: K151359, K172444

  • 2018

    • 8 May 2018 Z-2108-2018 Class II Terminated Replacement of units lacking an updated device approval. Distribution: US Distribution Submission number: K101791