Philips Azurion 5M12 Recall
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Philips Medical Systems Nederland B.V. is recalling three units of the Philips Azurion 5M12 due to a software issue that may produce a dark, unusable image during Roadmap Pro procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 11, 2026 and geographically references United States. 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Which Products Are Affected
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key. Three units are affected. UDI: (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63. Distributed nationwide in the United States. Recall number Z-2286-2026.
What You Should Do
No specific consumer actions are provided in the recall notice.
Why This Matters
The recall affects a small number of units used in clinical imaging procedures across the United States.
Source
FDA recall number Z-2286-2026, event ID 98977. Classification: Class II. Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Original source: FDA Official Notice ↗
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