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.
Recall
- Recall Number
- Z-1288-2021
- Event Number
- 87479
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- February 26, 2021
- Terminated
- August 11, 2021
- Address
- 40 Liberty Blvd, Malvern, PA, 19355
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.
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.
On 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.
US Nationwide distribution in the states of MI, KY, TX.
29 systems