The Recall Desk

Manufacturer

MEDTECH SAS

5 recalls in our database name MEDTECH SAS as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
1
Severe
1
Most recent
2021-11-03

Of the 5 recalls from MEDTECH SAS we have scored against our rubric, 1 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • CriticalFDA (Devices)·Z-0118-2022·2021-11-03

    Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement

    ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.

    Product
    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2020·2020-02-19

    Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors

    Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.

    Product
    ROSA Brain 3.0 Application-Brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0172-2020·2019-11-13

    Medtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors

    Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.

    Product
    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of inst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2018·2018-06-13

    Medtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues

    Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.

    Product
    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on
    Category
    Medical Device
    Distribution
    0 states