Recall Z-0730-2022— Siemens Medical Solutions USA, Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-03-07. It names one FDA 510(k) clearance: K201670. Product: 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-07
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
YSIO X.Pree
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.