PV Bulletin

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

Urgent field safety notice regarding several high voltage generators and digital angiography systems from Shimadzu. Users must identify the devices and cut the circuit breaker to ensure safety.

Primary source: Téléchargez le courrier de la société Shimadzu (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 field safety notice (FSN) was issued requiring users of the X-Ray High Voltage Generators UD150B-40, UD150V-40, UD150L-40, and others to identify the device and cut the circuit breaker.

Why it matters

These measures are vital to prevent potential safety risks associated with the use of the mentioned medical devices, which are crucial for medical imaging.

Action needed

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.

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 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.

A safety issue has been identified concerning various X-ray high voltage generator models and related digital angiography systems produced by Shimadzu. Detailed instructions for users are provided to ensure safety until interventions are completed.

What changed: A field safety notice (FSN) was issued requiring users of the X-Ray High Voltage Generators UD150B-40, UD150V-40, UD150L-40, and others to identify the device and cut the circuit breaker.

Why it matters: These measures are vital to prevent potential safety risks associated with the use of the mentioned medical devices, which are crucial for medical imaging.

Practical implication: 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.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:36.012Z

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

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