Artis Q — Class II medical device recall Z-2747-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-08-22, distributed nationwide. Potential hardware issue which may cause thermal effects and possible damage to system parts.
| Recall number | Z-2747-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2018-06-22 |
| Classified | 2018-08-10 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 605 units |
| Serial numbers | 103001, 103008, 103013, 103028, 103030, 103035, 103039, 103040, 103048, 103050, 103053, 103061, 103207, 103212, 103217, 103218, 103220, 103221, 103222, 103230, 103232, 103239, 103241, 103245, 103253 and 475 more |
| Model numbers | 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 |
Product
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Potential hardware issue which may cause thermal effects and possible damage to system parts.
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-2747-2018. 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.