FDA Recall of Philips S4-1 Ultrasound Transducer

FDA Recalls low FDA · · United States

The FDA has announced a voluntary recall of 41 units of Philips S4-1 Ultrasound Transducer to clarify labeling on their useful life, affecting devices distributed nationwide in the United States.

What this fda recalls alert tells you, and what most readers miss

This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "low" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Philips Ultrasound, Inc. is initiating a recall to provide clarification and labeling that defines the useful life of the Philips S4-1 Ultrasound Transducer devices.

Which Products Are Affected

The affected products are the Philips S4-1 Ultrasound Transducer with model numbers 989605458221, 989605458222, and 989605477101. The recall involves 41 units, identified by various UDIs such as (01)00884838085183(21)B25VV3 and serial numbers including B25VV3, B21XVK, and others listed in the recall details. Distribution occurred nationwide in the United States.

What You Should Do

Consumers who have the affected products should follow the initial firm notification, which was issued via letter, and contact the recalling firm for further instructions.

Why This Matters

This recall addresses potential issues with device labeling, ensuring accurate information for safe use, which is important for maintaining product reliability in medical settings.

Source

Attributed to the FDA; Recall Number Z-1625-2026.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
The FDA has announced a voluntary recall of 41 units of Philips S4-1 Ultrasound Transducer to clarify labeling on their useful life, affecting devices distributed nationwide in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.