ARTIS medical imaging systems recalled for mechanical connection failure
Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a structural mechanical defect in medical imaging equipment. Although no injuries or illnesses have been reported, the hazard presents a risk of harm if the tabletop detaches during use, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor imaging systems due to a potential mechanical failure. The mechanical connection between the tabletop and table base may be lost.
These systems have been distributed worldwide to the United States and 49 additional countries, affecting 550 units. The defect has been classified as FDA Class II.
The recalled systems can be identified by their product material numbers and UDI/DI codes: ARTIS pheno (Material #10849000, UDI: 4056869046877), ARTIS icono biplane (Material #11327600, UDI: 4056869063317), and ARTIS icono floor (Material #11327700, UDI: 4056869149325). Healthcare facilities can verify their equipment against these identifiers. Further information is available from Siemens Medical Solutions USA, Inc. and the FDA.
The recalled product
- Product
- ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Hazard
- mechanical-failure
- fall-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 1) ARTIS pheno
- Material #10849000
- UDI/DI: 4056869046877 2) ARTIS icono biplane
- Material #11327600
- UDI/DI: 4056869063317 3) ARTIS icono floor
- Material #11327700
- UDI/DI: 4056869149325
Distribution
Distributed nationwide across the United States.
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