FDA Announces Recall of Philips X3-1 Ultrasound Transducer
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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 read it 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 notices 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 recall 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
Original source: FDA Official Notice ↗
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