Z-1346-2021 Class II Terminated
FDA device recall Z-1346-2021 was initiated by Siemens Medical Solutions USA, Inc on March 10, 2021 and is designated Class II. Reason for recall: A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the cur… The recall status is terminated (terminated December 11, 2023). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 10, 2021
- Termination Date
- December 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
Reason for Recall
A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted
Distribution Pattern
US Nationwide distribution in the states of FL, MN, OH, PA, TX.
Code Information
Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045