CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Artis icono ceiling recalled by Siemens Medical Solutions USA
Siemens Medical Solutions USA is recalling Artis icono ceiling, distributed nationwide in the US. The recall was initiated on 20 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2642-2026
- FDA event ID
- 99079
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2026
- FDA classified
- 1 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 May 2026 | Recall initiated by company | |
| 1 Jul 2026 | Classified by FDA | +42 days |
| 8 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Product as listed by the FDA
ARTIS icono ceiling. Model Number: 11328100.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Which lots are affected?
Model Number: 11328100. UDI-DI: 4056869295923. Serial Numbers: 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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99079This product is part of a recall event; the main page for the event is Artis icono floor recalled by Siemens Medical Solutions USA.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
More recalls from Siemens Medical Solutions USA
All 796| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis pheno recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | PA |
| Device | CLASS II | Artis Icono biplane, floor and ceiling.: Artis icono biplane recalled | Siemens Medical Solutions USA | Other | PA |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |