Z-1288-2021 Class II Terminated
FDA device recall Z-1288-2021 was initiated by Siemens Medical Solutions USA, Inc on February 26, 2021 and is designated Class II. Reason for recall: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem. The recall status is terminated (terminated August 11, 2021). Affected quantity: 29 systems.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 systems
Product Description
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for Recall
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Distribution Pattern
US Nationwide distribution in the states of MI, KY, TX.
Code Information
ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700