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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the…"
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
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
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