FDAFDA · Food and drugs·Recall number Z-2642-2026
ARTIS icono ceiling. Model Number: 11328100.
Published July 8, 2026 · Recall initiated: May 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide distribution.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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