Date Initiated by Firm |
April 20, 2020 |
Date Posted |
May 04, 2020 |
Recall Status1 |
Terminated 3 on May 10, 2021 |
Recall Number |
Z-1958-2020 |
Recall Event ID |
85553 |
510(K)Number |
K181560
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. |
Code Information |
Serial Numbers: 40057 40047 40048 40107 40108 40111 40120 40126 40134 40135 40032 40104 40075 40102 40124 40070 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355
|
For Additional Information Contact |
SAME 610-219-4834
|
Manufacturer Reason for Recall |
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
|
FDA Determined Cause 2 |
Process design |
Action |
Siemens Healthcare issued A Customer Safety Advisory Notice dated 4/20/20 via AX030/20/S. Letter states reason for recall, health risk and action to take:
We strongly recommend that you do not disconnect the main unit from the monitor trolley when the system displays the system error message Err 16305 / 80: Confirm this error and repeat your last action until the problem has been corrected by a service engineer. Contact our service organization at 1-800-888-7436. Siemens is currently developing a solution to eliminate the root cause of this problem. |
Quantity in Commerce |
16 units |
Distribution |
US Nationwide distributions. |
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 Systems USA, Inc.
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