The Recall Desk
HighFDA (Devices)·Z-1469-2023·Announced 2023-05-03

Angiography system display malfunction affects diagnostic imaging capability

Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.

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 of a high-risk medical device where the hazard—loss of imaging function—could impair diagnosis and patient care. No injuries, illnesses, or deaths are reported in the source, placing it below Class I severity but within the 'High' category for risk-of-harm products without documented harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the ARTIS one angiography system (Material Number 10848600), a medical imaging device used for diagnostic imaging and interventional procedures. The device components affected in this recall include examination room monitors connected with the hybrid cable.

The hybrid cable connection may cause a display issue on the examination room monitor, resulting in loss of image function. This malfunction could impair the ability to view diagnostic images during clinical procedures.

Four units are affected in the United States, with distribution across Florida, South Dakota, and Puerto Rico. Affected serial numbers have been identified and are documented in the FDA recall notice. Additional units have been distributed worldwide across multiple countries and regions.

Facilities with affected equipment should contact Siemens Medical Solutions USA, Inc. for further information. The FDA classifies this as a Class II recall.

The recalled product

Product
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography System
Hazard
Affected units
4

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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