Z-2686-2017 Class II Terminated
FDA device recall Z-2686-2017 was initiated by Siemens Medical Solutions USA, Inc on February 3, 2017 and is designated Class II. Reason for recall: Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit. The recall status is terminated (terminated October 24, 2017). Affected quantity: 97 distributed worldwide, 12 distributed in United States.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2017
- Initiation Date
- February 3, 2017
- Termination Date
- October 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97 distributed worldwide, 12 distributed in United States
Product Description
Artis zee,x-ray system, angiographic Artis zee 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 zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Reason for Recall
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Distribution Pattern
Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Code Information
Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035