Z-0730-2022 Class II Ongoing
FDA device recall Z-0730-2022 was initiated by Siemens Medical Solutions USA, Inc on Mar 7, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 53 units
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.
Distribution Pattern
US Nationwide, Worldwide distribution
Code Information
11107464
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0730-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026