Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Reported: September 7, 2022 Initiated: August 10, 2022 #Z-1647-2022
Product Description
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1,389 (590 US; 799 OUS) (Total)
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1,389 (590 US; 799 OUS) (Total).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1647-2022.
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