Siemens ARTIS Angiography Systems Recalled for Rare Dose Reporting Error
Siemens recalled its ARTIS angiography systems worldwide due to rare communication failures between dose sensors and software that may cause incorrect dose reporting. No illnesses or injuries have been reported.
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 Class II recall involves a medical device with potential for incorrect radiation dose reporting due to rare software communication failures. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (Score 3).
Plain-English summary
The ARTIS family of angiography systems, manufactured by Siemens Medical Solutions USA, Inc., has been recalled worldwide. These dedicated diagnostic imaging systems are used for cardiac angiography, neuro-angiography, general angiography, and other interventional procedures.
In very rare situations, communication between the dose sensor and the corresponding software fails. As a result, the system may incorrectly report an application of a high dose. This communication failure can compromise the accuracy of dose reporting.
This recall affects ARTIS systems distributed worldwide.
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. Procedures that can be performed with the ARTIS family include cardiac angiography,
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- dose-reporting-error
- software-failure
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 (1)
- 4056869046877
Distribution
Distribution scope not specified by the agency.
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