Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error
Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 is classified as FDA Class II, and the product is a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Brainlab AG is recalling 17 units of the Navigation Spine & Trauma 3D software, versions 2.0 and 2.1. This software is an intraoperative image-guided localization system intended to enable minimally invasive surgery by linking a freehand probe to virtual computer image space on a patient's preoperative or intraoperative image data.
The recall is due to a defect in the software's automatic registration feature for intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. If automatic gantry communication is available, the software relies on this data, but the defect may affect the accuracy of this process.
The affected systems were distributed worldwide, including in the United States (specifically North Carolina, New York, Ohio, and Wisconsin) and in Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia. Healthcare facilities using this software should contact Brainlab AG for instructions on how to address the issue.
The recalled product
- Product
- Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's…
- Manufacturer
- Brainlab AG
- Affected units
- 17
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 (1)
- Model/Catalog Number: 19061-03
Distribution
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