Philips Medical Systems recalled 326 Azurion 5 M12 systems on January 26, 2026. The table may move unexpectedly when the Reset Geometry button is pressed, posing a risk to patients and healthcare providers. Immediate cessation of use is advised.
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 Azurion 5 M12 is a medical imaging system used in healthcare settings for diagnostic purposes. Healthcare providers rely on its functionality for patient procedures and assessments.
The hazard arises from the potential for the table to move unexpectedly, which can endanger patients during procedures. The malfunction can occur even when safety features, such as table locks, are activated.
This recall is not part of a broader industry pattern.
This recall significantly impacts healthcare providers who use the device, as it requires immediate cessation of use, potentially delaying patient care.
Model numbers and software versions are typically found on the device's label or in the user manual.
Expect a timeline of 4-6 weeks for processing any refunds or replacements once initiated.
Keep all related documents, including purchase receipts and correspondence with Philips as evidence.
The recall affects Azurion 5 M12 System Model Numbers 722227 and 722231. All versions of software R1.X, R2.X, and R3.X are included. The product has been distributed worldwide, with 10 units in the U.S. and 316 units internationally.
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