Siemens ARTIS Pheno Devices Recall

Source: FDA · United States

Siemens Medical Solutions USA, Inc. is recalling 73 units of ARTIS Pheno VE30A and VE40A devices due to potential inaccurate 3D imaging that may lead to low-dose radiation exposure.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 4, 2026 and geographically references United States. Its severity classification of "medium" 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 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

The recall involves ARTIS Pheno VE30A and VE40A devices where, during 3D acquisitions, images may vary in brightness, resulting in less accurate 3D reconstructions and possible unintentional low-dose radiation exposure to patients.

Which Products Are Affected

The affected products are ARTIS Pheno VE30A and VE40A, Model 10849000. A total of 73 units are involved, with UDI code 04056869046877. These devices were distributed in the U.S. and outside the U.S.

What You Should Do

Consumers should contact Siemens Medical Solutions USA, Inc. at their address, 40 Liberty Blvd, Malvern, PA 19355-1418, for information on returns or refunds related to recall number Z-1814-2026.

Why This Matters

This recall highlights potential risks in medical imaging devices that could affect patient safety through inaccurate reconstructions, emphasizing the need for precise equipment in healthcare settings.

Source

Attributed to the FDA, recall number Z-1814-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Siemens Medical Solutions USA, Inc. is recalling 73 units of ARTIS Pheno VE30A and VE40A devices due to potential inaccurate 3D imaging that may lead to low-dose radiation exposure.
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 "medium" severity. Stay informed and follow agency guidance.
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 updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.