Recall of Philips 3D6-2 Ultrasound Transducer
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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 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. 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
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 (1,323 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.