Artis icono biplane with software VE20C-diagnostic imaging… — Class II medical device recall Z-0516-2022

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2022-02-02, distributed nationwide. Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibr

Recall number	`Z-0516-2022`
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	2021-10-12
Classified	2022-01-21
Reported by FDA	2022-02-02
Terminated	2024-04-11
Distributed	Nationwide (US)
Quantity	72 units
Reason classes	software
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`, `180057`, `180060`, `180062`, `180065`, `180066`, `180067` and 47 more
Model numbers	`11327600`

Product

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

Reason for recall

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

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-0516-2022. 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.