Artis Icono — Class II medical device recall Z-1342-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-07-13, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. During system tests, an increased wearing of the Image acquisition system fans has been observed. This could l
| Recall number | Z-1342-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-05-20 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, JP, KR, NL, NO, NZ, OM, SA, SE, SG, TH, TW, VN, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04056869063317 |
| Serial numbers | 180014, 180015, 180018, 180019, 180021, 180029, 180034, 180035, 180037, 180040, 180041, 180043, 180046, 180047, 180048, 180049, 180053, 180054, 180055, 180056, 180057, 180060, 180062, 180065, 180066 and 63 more |
| Model numbers | 11327600 |
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Reason for recall
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1342-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.