Z-2240-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2024
- Initiation Date
- June 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 201 units in total
Product Description
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.
Reason for Recall
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Code Information
ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325