Z-2748-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- June 22, 2018
- Termination Date
- January 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 605 units in total
Product Description
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: 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, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068 164019 164013 164073 164025 164026 164027 164060 164083 164113 164021 164066 164075 164074 164084 164086 164098 164028 164053 164063 164064 164105 164024 164049 164018 164022 164061 164115 164100 164097 164011