News | Procedure Navigation Systems | February 05, 2019

Class I recall initiated due to inaccuracies displayed during surgical procedures

Medtronic Recalls Synergy Cranial Software and Stealth Station S7 Cranial Software

February 5, 2019 — Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures. The company said this could result in serious or life-threatening patient harm.

The Synergy Cranial Software and StealthStation S7 Cranial Software, used with the StealthStation Surgical Navigation System, provides detailed three-dimensional (3-D) images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.

During a biopsy procedure, Medtronic said the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

On Sept. 21, 2018, Medtronic sent an Urgent Medical Device Correction notice to customers. The notice provided the following mitigation to eliminate the risk of damaging healthy tissue:

  • Do not set a projection longer than the length of the surgical plan;

  • Follow the Cranial Software Pocket Guide, and always use the Biopsy Needle Mechanical Depth Stop; and

  • Ensure the Navigate Instrument Tip setting is selected prior to locking the trajectory and navigating the instrument.

The notice also instructed customers to take the following actions:

  • Review the notice and ensure appropriate staff are aware of the issue;

  • Sign and date the Consignee Response Form attached to the notice, and return the form to Medtronic by email at [email protected] or fax to Medtronic Technical Services at 651-367-7075 within 30 days of receipt.

On Dec. 28, Medtronic reported they were continuing to follow up with customers about  their Urgent Medical Device Correction over the next months.

Affected model numbers include:

  • 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
  • 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0

All affected devices were manufactured from Aug. 31, 2011, to Oct. 16, 2018, and were distributed between the same dates.

Customers who have questions or need additional information or support related to this recall should contact Medtronic Technical Services at 1-888-826-5603. Healthcare professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.

For more information:

Related Content

News | Neuro Imaging

July 2, 2021 — Researchers at the University of Chicago and the U.S. Department of Energy's (DOE) Argonne National ...

Time July 02, 2021
Videos | Artificial Intelligence

Pooja Rao, Ph.D., co-founder of Qure.AI and head of research and development for the company, explains how the company's ...

Time July 31, 2020
Feature | Coronavirus (COVID-19) | Dave Fornell, Editor

Four recent radiology studies, from New York, Italy, Iran and China, show how COVID-19 (SARS-CoV-2) impacts the brain of ...

Time July 06, 2020
News | Nuclear Imaging

December 26, 2019 — The Feinstein Institutes for Medical Research has received U.S. Food and Drug Administration (FDA) ...

Time December 26, 2019
News | Magnetic Resonance Imaging (MRI)

November 28, 2019 — Individuals with functional neurological disorder (FND) have symptoms not explained by traditional ...

Time November 28, 2019
News | Clinical Trials

October 29, 2019 — A UCLA-led study finds that, with the use of magnetic resonance imaging (MRI) scans, it is possible ...

Time October 29, 2019
News | Orthopedic Imaging

October 24, 2019 — EOS imaging announced the first patient cases performed with its hipEOS 3.0 surgical planning ...

Time October 24, 2019
News | Artificial Intelligence

To help advance medical research while preserving data privacy and improving patient outcomes for brain tumor identification, NVIDIA researchers in collaboration with King’s College London researchers recently announced the introduction of the first privacy-preserving federated learning system for medical image analysis. NVIDIA is working with King’s College London and French startup Owkin to enable federated learning for the newly established London Medical Imaging and AI Centre for Value Based Healthcare.

Time October 23, 2019
News | Orthopedic Imaging

International medical imaging information technology (IT) and cybersecurity company Sectra is extending its pre-operative orthopedic planning solution for trauma cases with 3-D templates from one of the largest orthopedic companies, DePuy Synthes. Pre-operative planning for trauma cases using templating in combination with 3-D computed tomography (CT) images enables improved surgical outcomes.

Time October 17, 2019
News | Neuro Imaging

Guerbet announced it has signed an exclusive agreement with Icometrix for the distribution in France, Italy and Brazil of icobrain, their software-as-a-service (SaaS) artificial intelligence (AI)-based medical imaging solution.

Time October 16, 2019
Subscribe Now