The Recall Desk
HighFDA (Devices)·Z-0282-2016·Announced 2015-11-25

Brainlab IGS System Recalled for Inaccurate Patient Anatomy Registration

Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.

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 is classified as FDA Class II. The hazard involves a risk-of-harm product (surgical navigation) where inaccurate registration could lead to injury, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Brainlab AG is recalling 12 BrainLAB Image Guided Surgery (IGS) systems, specifically the Stereotaxic Instrument navigation software (Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1). The recall involves the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices.

The recall was initiated because instances of data sets not being accurately registered to the patient anatomy were observed. This system is an intraoperative image-guided localization system used to enable minimally invasive surgery.

A total of 12 systems are affected, with 10 located in the United States and 2 in Australia. The specific model numbers involved are 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM and 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL.

The recalled product

Product
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
Manufacturer
Brainlab AG
Category
Medical Device — Surgical Navigation
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 (1)

  • Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Brainlab AG

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