Siemens ARTIS Pheno Devices Recall
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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 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
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 ↗
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 (982 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 4, 2026.
Frequently Asked Questions
Common questions about this FDA recall.