Philips Medical Systems recalled 291 Azurion 3 M12 systems on January 26, 2026, due to a risk of unexpected table movement. This may occur when the Reset Geometry button is pressed, even if a table lock is active. The recall affects 27 units in the U.S. and 264 units internationally.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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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The recalled Azurion 3 M12 systems include model numbers 722063, 722221, and 722229. All software versions R1.X, R2.X, and R3.X are affected. The systems were distributed worldwide.
Under specific conditions, the Azurion 3 M12 system table may move unexpectedly. This can create a high risk of injury to patients and healthcare providers.
There are no reported injuries or incidents associated with this recall as of the report date. The potential for unexpected movement poses a significant safety concern.
Patients and healthcare providers should stop using the Azurion 3 M12 systems immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.
For more information, contact Philips Medical Systems Nederland B.V. at the appropriate customer service number or visit the FDA recall page.
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