PV Bulletin

TD Navio Midi and TD Navio Maxi Devices – Tobii Technology AB

Safety notice issued for TD Navio Midi and TD Navio Maxi devices due to potential mechanical integrity issues with the battery structure.

Primary source: Téléchargez le courrier de la société Tobii Technology AB (10/09/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

A safety notice (FSCA-2026-00001) was issued requiring corrective actions to be taken by users of the TD Navio Midi and TD Navio Maxi devices within 60 days of receipt of notification.

Why it matters

Addressing potential mechanical failures in the device is crucial to prevent safety hazards such as battery overheating or gas release, maintaining user safety and device reliability.

Action needed

Users must send affected devices for repair to ensure continued safe operation. Notification of the issue must be disseminated to all users and organizations that have been supplied with the devices.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 10, 2026

Full briefing

Practical implication

Users must send affected devices for repair to ensure continued safe operation. Notification of the issue must be disseminated to all users and organizations that have been supplied with the devices.

Tobii Technology AB has issued a safety notice regarding the TD Navio Midi and TD Navio Maxi devices, indicating a mechanical stability issue with the internal battery structure that may lead to battery displacement and potential internal short-circuiting if the devices are subjected to significant drops or mechanical stress. Users are advised to read the notice carefully and take necessary precautions.

What changed: A safety notice (FSCA-2026-00001) was issued requiring corrective actions to be taken by users of the TD Navio Midi and TD Navio Maxi devices within 60 days of receipt of notification.

Why it matters: Addressing potential mechanical failures in the device is crucial to prevent safety hazards such as battery overheating or gas release, maintaining user safety and device reliability.

Practical implication: Users must send affected devices for repair to ensure continued safe operation. Notification of the issue must be disseminated to all users and organizations that have been supplied with the devices.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:36.016Z

Published from the regulator source ingestion pipeline after PV impact triage.

Related updates for your role

publicANSM (France) · France · Updated Sep 10, 2026Translated From French

X-Ray High Voltage Generators UD Type and ZUD Type – Shimadzu Safety Alert

Urgency: High

Users must identify the affected devices and take immediate action to cut the power supply by turning off circuit breakers. These actions should remain in effect for a period of 3 years.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 9, 2026Translated From French

QIAstat-Dx Gastrointestinal Panel 2 – Qiagen Safety Information

Urgency: High

Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Latest
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 10, 2026Translated From French

ANSM Disseminates Personalized Letter to Women Regarding Very Low Risk of Meningioma Associated with Desogestrel-based Contraceptives

Urgency: High

Healthcare professionals should review the contraceptive needs of women annually and discuss the implications of continued desogestrel use, particularly in women over 45 or with a history of progestin use.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicTGA · Australia · Updated Sep 10, 2026

Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables

Urgency: High

Monitoring of the affected batches will be essential to ensure regulatory compliance and consumer safety, alongside implementation of any necessary recall procedures.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Latest
Read impact briefarrow_forward