# FDA recall Z-1645-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-08-10.

## Product

Artis Q floor- Model No. 10848280  Artis Q ceiling- Model No. 10848281  Artis Q biplane- Model No. 10848282  Artis Q zeego- Model No. 10848283  Artis Q.zen floor- Model No. 10848353  Artis Q.zen ceiling- Model No. 10848354  Artis Q.zen biplane- Model No. 10848355

## Reason for recall

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

## Distribution

Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan;  Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.

## Key facts

- **Recall number:** Z-1645-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-10
- **Report date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2022

## Citation

> AI Analytics. FDA recall Z-1645-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1645-2022. Source: US FDA. Licensed CC0.

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