The Recall Desk
HighFDA (Devices)·Z-0598-2016·Announced 2016-01-27

Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy

Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in surgery where a software error could lead to inaccurate instrument display relative to patient anatomy. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Brainlab AG is recalling the Brainlab Cranial Navigation System, an intra-operative image-guided localization system used for minimally invasive surgery. The recall involves 2,528 units distributed to 2,119 consignees worldwide, including the United States and numerous international locations.

The recall is due to a software error where the effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure. This may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.

Hospitals and radiology departments using the affected software should contact Brainlab AG for further instructions on how to address the issue.

The recalled product

Product
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Manufacturer
Brainlab AG
Category
Medical Device — Surgical Navigation Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) Model 22035
  • VVC NAVIGATION SOFTWARE CRANIAL 5.0
  • Serial Numbers: 22035-103911-004
  • 22035-103953-001
  • 22035-103977-001
  • 22035-103982-002
  • 22035-103987-001
  • 22035-103988-001
  • 22035-104566-001
  • 2) Model 22040
  • VV NAVIGATION SOFTWARE CRANIAL 4.0
  • Serial Numbers: 22040/18820
  • 22040/21370
  • 22040/26909
  • 22040/36997
  • 22040-103675-006
  • 22040-103687-009
  • 22040-103710-001
  • 22040-103942-008
  • 22040-103974-011

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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Same hazard · software error

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