Date Initiated by Firm |
February 26, 2021 |
Create Date |
March 22, 2021 |
Recall Status1 |
Terminated 3 on August 11, 2021 |
Recall Number |
Z-1288-2021 |
Recall Event ID |
87479 |
510(K)Number |
K193326
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
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. |
Code Information |
ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355
|
For Additional Information Contact |
Meredith Adams 610-448-6478
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
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. |
Quantity in Commerce |
29 systems |
Distribution |
US Nationwide distribution in the states of MI, KY, TX. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions USA, Inc.
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