Philips Azurion Systems Recall
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 1,718 Azurion systems due to potential loosening or breaking of cable hose carrier bolts and parts.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 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
Philips Medical Systems Nederland B.V. initiated a voluntary recall of certain Azurion systems because the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Which Products Are Affected
The recall affects 1,718 units of Philips Azurion systems distributed worldwide, including US Nationwide and Canada. Affected models include: Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282). The recall number is Z-2170-2026. Specific UDI codes for each model are listed in the FDA recall entry.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter. Contact the recalling firm for further guidance on affected units.
Why This Matters
The potential failure of the cable hose carriers could affect the safe positioning of monitors during use of these medical imaging systems.
Source
FDA recall Z-2170-2026 (Class II, ongoing).
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 (1,332 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.