MEDTECH SAS: Medical Device Recall in 2020 - (Recall #: Z-1151-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ROSA One 3.1 Brain Application

Product Classification:

Class II

Date Initiated: January 6, 2020

Date Posted: February 19, 2020

Recall Number: Z-1151-2020

Event ID: 84642

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.

Status: Terminated

Product Quantity: 39 units

Code Information:

Serial Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038; 3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043; 7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049; 8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052; 10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054; 11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057; 12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058.

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated