FDA Announces Recall of Philips X3-1 Ultrasound Transducer
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 recall 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 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, Devices.
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
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 (1,152 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.