FDA recall Z-1346-2021

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

US Nationwide distribution in the states of FL, MN, OH, PA, TX.

Key facts

Status
Terminated
Initiation date
2021-03-10
Report date
2021-04-14
Termination date
2023-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2021