HIGH

Philips Medical Systems Recalls Azurion 3 M15 System Due to Hazard

Philips Medical Systems Nederland B.V. recalled 802 Azurion 3 M15 systems on January 26, 2026. The systems may move unexpectedly, posing a risk to patients and healthcare providers. Consumers should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
January 26, 2026
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: N/A

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Product Details

The recalled models include Azurion 3 M15 System Model Numbers: 722064, 722222, 722230, and 722280 (OUS only). Affected software versions include R1.X, R2.X, R3.X. The systems were distributed worldwide, with 45 units in the U.S. and 757 units in other countries.

The Hazard

The device may move unexpectedly when the Reset Geometry button is pressed, even if a table lock is active. This movement can lead to potential harm to patients during medical procedures.

Reported Incidents

There are no reported injuries or incidents associated with the recalled systems. The recall is classified as Class II due to its potential high hazard level.

What to Do

Stop using the Azurion 3 M15 system immediately. Contact Philips Medical Systems or your healthcare provider for further instructions on the recall.

Contact Information

For more information, contact Philips Medical Systems Nederland B.V. at their official website or the FDA's recall page.

Key Facts

  • 802 units recalled
  • Movement hazard when using Reset Geometry
  • No reported injuries
  • Immediate cessation of use advised

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
722064
722222
722230
722280
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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