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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Device Recall Siemenssee related information
Date Initiated by FirmMarch 22, 2019
Create DateMay 07, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-1295-2019
Recall Event ID 82613
510(K)NumberK181560 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductCios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Code Information Cios Alpha system with SW VA30
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
FDA Determined
Cause 2		Device Design
ActionSiemens issued Customer Safety Advisory Letter dated 3/22/19 advising of problem, health risk and action to take: recommends to avoid overwriting the organ programs, as this can lead to frequent operations. Siemens is distributing this letter and the addendum to the user manual to all potentially affected users Contact our service organization for any additional questions at 1-800-888-7436.
Quantity in Commerce 2 US
DistributionUS Nationwide Distribution in the states of NC, MA
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = OWB
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