Agency classClass IIOur severity:High FDA (Devices)·Z-2241-2024·Announced 2024-07-10

Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses

Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device with potential for increased radiation exposure in patients. Source explicitly states no illnesses or injuries reported and the defect occurs in 'very rare situations,' but unintended radiation dose escalation on a medical imaging system constitutes a risk-of-harm scenario that warrants High severity.

Plain-English summary

Siemens has issued a recall for the ARTIS icono family of angiography systems equipped with a small detector and matching collimator (model 10843101). These are medical imaging systems used for diagnostic and interventional procedures in patients of varying sizes, including pediatric and obese patients.

In very rare situations, the first x-ray exposure following patient registration may be performed with incorrect copper prefiltration. When this occurs, the radiation dose rate delivered to the patient may be higher than the user intended.

A total of 201 ARTIS icono systems are affected by this recall, distributed worldwide and throughout the United States (including Texas, Massachusetts, New Hampshire, Minnesota, Oklahoma, New Jersey, South Carolina, New York, Michigan, Illinois, Missouri, and North Carolina). Customers are instructed to contact Siemens for further guidance and corrective measures.

The recalled product

Product: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Manufacturer: Siemens AG/Siemens Healthcare GmbH
Category: Medical Device — Angiography System
Hazard: radiation-overdose
calibration-error
Affected units: 201

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Siemens AG/Siemens Healthcare GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens AG/Siemens Healthcare GmbH

See all →

High
ARTIS Angiography Systems Recalled for Potential Radiation Overdose
FDA (Devices) · 2024-07-10
High
Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose
FDA (Devices) · 2024-07-10

Same hazard · radiation overdose