Philips Medical Systems Netherlands B.V. recalled 655 Azurion 7 B12 systems on January 26, 2026. The recall affects models 722067, 722225, and 722235 due to unexpected table movement when the Reset Geometry button is pressed. This poses a high risk of injury to patients and healthcare providers.
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 7 B12 System includes model numbers 722067, 722225, and 722235, with all software versions R1.X, R2.X, and R3.X. The systems were distributed worldwide, with 106 units in the U.S. and 549 units in other countries.
Under certain conditions, the Azurion 7 B12 table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active. This defect poses a serious risk of injury to patients and healthcare providers in medical settings.
No specific incidents or injuries have been reported as of the recall date. However, the nature of the hazard indicates a high risk of potential injury.
Stop using the recalled systems immediately. Contact Philips Medical Systems or your healthcare provider for further instructions on how to proceed.
For more information, contact Philips Medical Systems Netherlands B.V. at their customer service number or visit their website at www.accessdata.fda.gov.
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