Recall Z-1151-2020— MEDTECH SAS

Name: FDA recall Z-1151-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-06

Class II · Terminated

Class II FDA medical device recall by MEDTECH SAS, initiated 2020-01-06, terminated 2020-11-05. It names 3 FDA 510(k) clearances: K182417, K172444, K151359. Product: ROSA One 3.1 Brain Application. Reason: 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..

Recalling firm: MEDTECH SAS
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Terminated: 2020-11-05
Firm location: Montpellier, France

510(k) clearances named in this recall

3 on FDA's record

K182417 — ROSA ONE Brain ApplicationMedtech S.A·cleared 2019-02-07
K172444 — ROSA BRAIN (v3.0.0.5)Medtech S.A·cleared 2018-03-28
K151359 — ROSA BrainMedtech S.A·cleared 2015-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ROSA One 3.1 Brain Application

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.