ROSA Brain

• 2 recalls, same reason

  • Terminated Z-1150-2020 FDA Class II ·initiated 6 Jan 2020
  • Terminated Z-1151-2020 FDA Class II ·initiated 6 Jan 2020

  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.

• • Terminated Z-0172-2020 FDA Class I ·initiated 10 Sep 2019

  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.

• • Terminated Z-1754-2017 FDA Class II ·initiated 27 Feb 2017

  Unapproved change made by the supplier.

• • Terminated Z-2868-2017 FDA Class II ·initiated 11 Oct 2016

  Complaint of the head holder connector locking up mechanically when tightened.

• • Terminated Z-0116-2018 FDA Class II ·initiated 29 Jul 2016

  Non-conforming product label.

• • Terminated Z-0167-2018 FDA Class II ·initiated 20 Jul 2016

  Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.

510(k) Number

K151359 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• ROSA ONE Spine application

  Class II

  FDA 510(k) K192173 Active Cleared 29 Oct 2019

• ROSA BRAIN (v3.0.0.5)

  Class II

  FDA 510(k) K172444 Active Cleared 28 Mar 2018

• Rosa Surgical Device, Model Rosa 1.1

  Class II

  FDA 510(k) K092239 Active Cleared 17 Nov 2009

• ROSA Spine

  Class II

  FDA 510(k) K151511 Active Cleared 4 Jan 2016

• ROSA ONE Brain Application Open recall

  Class II

  FDA 510(k) K182417 Active Cleared 7 Feb 2019

• ROSA ONE Spine application

  Class II

  FDA 510(k) K182848 Active Cleared 22 Mar 2019

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