The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health

Monday, November 18, 2019

Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

Zimmer Rosa Robotic System.

Robotic surgery has become fairly common in neurosurgery, spine surgery, and knee surgery. It is  also used for abdominal and prostate surgery. It provides for exact control using computer software providing fine precision motor control, eliminating tremor or inadvertent movement by a surgeon. It also allows for minimally invasive surgery reducing the size of the wound.  Healing and recovery time is markedly diminished, shortening hospital stays and reducing cost. The robotic arm allow for minimal axial movement while allowing the cutting or holding instrument to have larger translational movement.




How the Rosa Knee Device is used

How the Rosa Brain Device is used




Device Use
The ROSA Brain device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm depending on the procedure to be completed.

Reason for Recall

Zimmer Biomet recalled the ROSA Brain Device due to a software issue with ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported.

Who May be Affected

  • Neurosurgeons and assisting medical personnel who use the ROSA Brain device in the operating room.
  • Patients receiving neurosurgery during which the ROSA Brain device is used.

What to do?

Zimmer has already contacted all customers regarding the issue. The defective units will not be used until the upgrade has been certified. Zimmer is sending technical personnel to upgrade the current software with a new version.

Details of the recall are displayed on the Food and Drug Administration Recall List


Navigation and Robotics in Spinal Surgery: Where Are We Now?

Neurosurgery, Volume 80, Issue 3S, March 2017, Pages S86–S99,

 Zimmer is not alone in robotic surgery devices.

Spine surgery has experienced much technological innovation over the past several decades. The field has seen advancements in operative techniques, implants and biologics, and equipment such as computer-assisted navigation and surgical robotics. With the arrival of real-time image guidance and navigation capabilities along with the computing ability to process and reconstruct these data into an interactive three-dimensional spinal “map”, so to have the applications of surgical robotic technology. While spinal robotics and navigation represent a promising potential for improving modern spinal surgery, it remains paramount to demonstrate its superiority as compared to traditional techniques prior to the assimilation of its use amongst surgeons.
The applications for intraoperative navigation and image-guided robotics have expanded to surgical resection of the spinal column and intradural tumors, revision procedures on arthrodesis spines, and deformity cases with distorted anatomy. Additionally, these platforms may mitigate much of the harmful radiation exposure in minimally invasive surgery to which the patient, surgeon, and ancillary operating room staff are subjected.
Spine surgery relies upon meticulous fine motor skills to manipulate neural elements and a steady hand while doing so, often exploiting small working corridors utilizing exposures that minimize collateral damage. Additionally, the procedures may be long and arduous, predisposing the surgeon to both mental and physical fatigue. In light of these characteristics, spine surgery may actually be an ideal candidate for the integration of navigation and robotic-assisted procedures.
Spinal robotic surgery, as well as Brain robotic surgery, requires tight integration of positioning and imaging. 
Airo Mobile (Brainlab©) CT scanner with an attached, mobile, pivoting OR table.


Stryker SpineMask© Tracker (Stryker©) noninvasive rectangular tracker
The Da Vinci telesurgical robotic system (Intuitive Surgical) with remote surgeon kiosk and robotic arms.
















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