Artis Q — Class II medical device recall Z-1341-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-05-22, distributed nationwide. In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has be
| Recall number | Z-1341-2019 |
|---|---|
| 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 | 2019-04-09 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-04-23 |
| Distributed | Nationwide (US) |
| Serial numbers | 103277, 103279, 103285, 103286, 103293, 103295, 103302, 103310, 109496, 109497, 109500, 109501, 109502, 109503, 109504, 109505, 109507, 109512, 109515, 109518, 109520, 109523, 109524, 109525, 109526 and 46 more |
Product
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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 AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
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-1341-2019. 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.