Siemens ARTIS icono ceiling Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Siemens Medical Solutions USA, Inc. is recalling 119 units of the ARTIS icono ceiling device nationwide due to potential loss of movement capability.

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

This notice was issued by FDA on August 8, 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, medical-device.

What Happened

Siemens Medical Solutions USA, Inc. initiated a voluntary recall of the ARTIS icono ceiling device after reports of potential loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. The recall is classified as Class II by the FDA.

Which Products Are Affected

The recall affects the ARTIS icono ceiling, Model Number: 11328100, with UDI-DI 4056869295923. A total of 119 units distributed nationwide in the United States are involved. Affected serial numbers include: 194180, 194184, 194169, 194101, 194131, 194223, 194193, 194216, 194215, 194080, 194186, 194164, 194102, 194054, 194181, 194185, 194194, 194188, 194095, 194094, 194093, 194090, 194086, 194203, 194037, 194116, 194114, 194207, 194209, 194120, 194177, 194036, 194038, 194213, 194103, 194190, 194096, 194139, 194165, 194066, 194210, 194098, 194221, 194072, 194047, 194212, 194226, 194197, 194141, 194039, 194088, 194204, 194113, 194222, 194083, 194128, 194219, 194146, 194145, 194099, 194205, 194200, 194081, 194082, 194218, 194147, 194189, 194109, 194183, 194187, 194105, 194119, 194201, 194050, 194049, 194174, 194199, 194079, 194135, 194085, 194125, 194034, 194121, 194111, 194158, 194092, 194133, 194220, 194192, 194071, 194136, 194182, 194161, 194162, 194211, 194127, 194126, 194124, 194123, 194122, 194108, 194175, 194035, 194225, 194149, 194107, 194208, 194104, 194089, 194227, 194041, 194040, 194173, 194179, 194163, 194172, 194143, 194117, 194144. The recalling firm is located at 40 Liberty Blvd, Malvern, PA 19355-1418. Recall number Z-2642-2026.

What You Should Do

The firm initiated the recall via letter. Consumers with affected units should contact Siemens Medical Solutions USA, Inc. for additional guidance.

Why This Matters

The recall involves 119 units distributed across the United States and addresses a potential device malfunction in medical imaging equipment.

Source

FDA recall Z-2642-2026

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Siemens Medical Solutions USA, Inc. is recalling 119 units of the ARTIS icono ceiling device nationwide due to potential loss of movement capability.
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.