—#192328

Product

YSIO X.Pree

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K201670
Affected lot / code info: 11107464

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide, Worldwide distribution

Timeline

Recall initiated: 2022-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.