Philips Medical Systems Recalls Azurion 7 B12 Systems Due to Unexpected Table Movement
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Philips Medical Systems has issued a voluntary recall for 655 Azurion 7 B12 medical imaging systems worldwide due to a software issue that causes unexpected table movement.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 B12 System. The recall was issued because, under certain conditions, the system's table may move unexpectedly when the "Reset Geometry" button is pressed. This movement can occur even when a table lock is currently active.
Which Products Are Affected
The recall impacts a total of 655 units, with 106 located in the United States and 549 distributed internationally. The following Azurion 7 B12 System models and software versions are included:
- Model Numbers: 722067, 722225, 722235
- Software Versions: All versions (R1.X, R2.X, R3.X)
- UDI-DIs: 884838085350, 884838099265, 884838116788
- Serial Numbers: All serial numbers for the listed models are affected.
What You Should Do
Healthcare providers and facilities using the Azurion 7 B12 System should exercise caution when using the "Reset Geometry" button, particularly regarding the potential for unexpected table movement. Owners of the affected units should contact Philips Medical Systems Nederland B.V. at their Veenpluis 4-6 address in the Netherlands or through their official service channels for guidance on necessary software updates or corrective actions.
Why This Matters
This Class II recall highlights a mechanical safety risk where unintended equipment movement could potentially cause injury to patients or medical staff during imaging procedures.
Source
Information provided by the FDA. Recall Number: Z-1346-2026.
Original source: FDA Official Notice ↗
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