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Incident · Recall

Brainlab recalls spine 3D navigation software for incorrect display

Brainlab recalled its spine and trauma 3D navigation software after the FDA reported it could incorrectly display patient anatomy during surgery. The company planned to stop distributing the software until an updated version was released.

Occurred 2019-07-10 · Loop-X at Hospital San Juan de Dios León · Brainlab · Hospital San Juan de Dios León · Surgical robots

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (1)

  1. https://www.medtechdive.com/news/brainlab-recalls-spine-3d-navigation-software-for-incorrect-display/552904/ · 2019-07-10

Status history

  • Active · 2019-07-10

Common questions

What happened in Brainlab recalls spine 3D navigation software for incorrect display?
Brainlab recalled its spine and trauma 3D navigation software after the FDA reported it could incorrectly display patient anatomy during surgery. The company planned to stop distributing the software until an updated version was released.
When did this incident occur?
The incident is recorded as occurring on July 10, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Brainlab recalls spine 3D navigation software for incorrect display?
Loop-X by Brainlab is the recorded robot involved in this incident at Hospital San Juan de Dios León.
Has anyone responded to Brainlab recalls spine 3D navigation software for incorrect display?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Brainlab recalls spine 3D navigation software for incorrect display?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
secondary-trade-publication
Trade publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Brainlab recalls spine 3D navigation software for incorrect display.

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Canonical ID 8a92a297-9484-4094-8329-e83a426db800