Philips Recalls Azurion 7 M12 Systems Due to Unexpected Table Movement Hazard
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Philips Medical Systems is recalling Azurion 7 M12 systems because the patient table may move unexpectedly during geometry resets, even when locks are active.
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 M12 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, potentially creating a safety hazard during medical procedures.
Which Products Are Affected
The recall involves 1,979 units globally, including 365 units distributed across the United States. The following models and software versions are affected:
- Product Name: Azurion 7 M12 System
- Model Numbers: 722078, 722223, 722233
- Software Versions: All versions (R1.X, R2.X, R3.X)
- UDI-DIs: 884838085251, 884838099241, 884838116764
- Serial Numbers: All serial numbers for the specified models are included.
What You Should Do
As this is a firm-initiated voluntary recall, healthcare facilities using these systems should be aware of the risk of unexpected table movement when utilizing the Reset Geometry function. Operators should exercise caution even when table locks are engaged. For further information regarding the recall (Recall Number: Z-1348-2026), facilities should refer to the official notifications provided by Philips Medical Systems.
Why This Matters
Unexpected movement of a medical procedure table poses a risk of injury to both patients and clinical staff. The failure of the table lock to prevent movement during a geometry reset could lead to complications during sensitive medical imaging or interventions.
Source
FDA - Recall Number: Z-1348-2026
Original source: FDA Official Notice ↗
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