Recall of Philips 3D6-2 Ultrasound Transducer
Philips Ultrasound, Inc. is voluntarily recalling 17 units of the Philips 3D6-2 Ultrasound Transducer to provide clarification on its useful life through updated labeling.
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. initiated a voluntary recall to provide clarification and labeling that defines the useful life of the Philips 3D6-2 Ultrasound Transducer.
Which Products Are Affected
The affected products are the Philips 3D6-2 Ultrasound Transducer with Model No. 989605326521, 989605440872, and 989605440871. The recall involves 17 units distributed nationwide in the United States. Specific codes include UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; and Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.
What You Should Do
Affected users should follow the initial firm notification, which was sent via letter, and contact Philips Ultrasound, Inc. at their address: 1 Echo Dr, Reedsville, PA 17084-8603 for further instructions on the recall.
Why This Matters
This recall addresses potential issues with device labeling to ensure proper understanding of the ultrasound transducer's useful life, which is important for maintaining safety and effectiveness in medical settings.
Source
FDA Recall Number Z-1618-2026
Source: FDA Official Notice