Philips Azurion 7B20/15 Recall Due to Dark Image Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips Medical Systems Nederland B.V. is recalling 156 units of the Azurion 7B20/15 system due to a software issue that can 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 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, medical-devices.
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 7B20/15, Model Numbers: 722068, 722226 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. 156 units are affected. Distribution was US Nationwide. Recall number Z-2289-2026. Multiple UDI codes are associated with the affected units.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter.
Why This Matters
The recall affects 156 units distributed nationwide and involves a Class II device that may produce images unusable for clinical procedures.
Source
FDA recall Z-2289-2026, initiated December 7, 2023.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (983 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.