FDA Recall Open, Classified

YSIO X.Pree

Recall: Z-0730-2022 · Initiated March 7, 2022

Recall

Recall Number
Z-0730-2022
Event Number
89738
Firm
Siemens Medical Solutions USA, Inc
FEI Number
2240869
Product Code
KPR
Status
Open, Classified
Root Cause
Software design
Initiated
March 7, 2022
Address
40 Liberty Blvd, Malvern, PA, 19355-1418

Description

YSIO X.Pree

Reason

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.

Action

Siemens 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.

Distribution

US Nationwide, Worldwide distribution

Quantity

53 units