PV Bulletin

Philips MRI Systems with Software Versions R5 and R11 Safety Notification

Philips issued a safety notification regarding potential software issues in MRI systems using versions R5 and R11, which may cause examinations to fail.

Primary source: Téléchargez le courrier de la société Philips Medical Systems (03/09/2026)

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 notification was issued outlining specific issues with Philips MRI systems using software versions R5 and R11, highlighting risks associated with incorrect parameter settings that could cause system freezes.

Why it matters

Failing examinations could necessitate repeat tests, increasing patient exposure to sedation or contrast agents, potentially leading to additional health risks.

Action needed

Healthcare facilities are advised to adhere to standard acquisition protocols or modify parameters as recommended, with a requirement to respond to Philips within 30 days of notification.

Relevant for
Regulatory Intelligence 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 3, 2026

Full briefing

Practical implication

Healthcare facilities are advised to adhere to standard acquisition protocols or modify parameters as recommended, with a requirement to respond to Philips within 30 days of notification.

Philips has alerted healthcare providers about a potential safety issue affecting MRI systems that could lead to exam cancellations during image reconstruction due to insufficient memory allocation when custom parameters exceed system limits.

What changed: A safety notification was issued outlining specific issues with Philips MRI systems using software versions R5 and R11, highlighting risks associated with incorrect parameter settings that could cause system freezes.

Why it matters: Failing examinations could necessitate repeat tests, increasing patient exposure to sedation or contrast agents, potentially leading to additional health risks.

Practical implication: Healthcare facilities are advised to adhere to standard acquisition protocols or modify parameters as recommended, with a requirement to respond to Philips within 30 days of notification.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-03T00:00:00.000Z
  • Discovered by monitor: 2026-09-03T21:47:55.796Z

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

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