Siemens ARTIS icono ceiling Recall
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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Similar body length
Nearest notices by article body length (1,954 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.