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U.S. Department of Health and Human Services

Class 2 Device Recall YSIO X.Pree

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 Class 2 Device Recall YSIO X.Preesee related information
Date Initiated by FirmMarch 07, 2022
Create DateApril 05, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0730-2022
Recall Event ID 89738
510(K)NumberK201670 
Product Classification System, x-ray, stationary - Product Code KPR
ProductYSIO X.Pree
Code Information 11107464
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.
FDA Determined
Cause 2		Software design
ActionSiemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers. The letter inform customers that the firm will distribute a software correction via update instruction at no cost to the customers.
Quantity in Commerce53 units
DistributionUS Nationwide, Worldwide distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPR
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