FDA Announces Recall of Philips X3-1 Ultrasound Transducer

FDA Recalls low FDA · · United States

Philips Ultrasound, Inc. is voluntarily recalling 17 units of the Philips X3-1 Ultrasound Transducer to provide clarification on its 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.

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What Happened

Philips Ultrasound, Inc. is initiating a recall to provide clarification and labeling to define the useful life of the Philips X3-1 Ultrasound Transducer. This is a voluntary, firm-initiated action classified as Class III by the FDA.

Which Products Are Affected

The affected products are the Philips X3-1 Ultrasound Transducer with model numbers: 989605440742, 989603002321, 989605388101, and 989605440741. A total of 17 units are involved, with specific UDIs such as (01)00884838067615(21)033TVZ and serial numbers including 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, and 02JK8D. These units were distributed nationwide in the United States.

What You Should Do

Consumers should follow the initial firm notification, which is a letter from Philips Ultrasound, Inc., for further instructions on this recall.

Why This Matters

This recall helps ensure proper clarification of the useful life for ultrasound transducers, supporting the safe and effective use of medical devices in healthcare settings.

Source

FDA Recall Notice Z-1627-2026

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
Philips Ultrasound, Inc. is voluntarily recalling 17 units of the Philips X3-1 Ultrasound Transducer to provide clarification on its 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.