PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 14, 2021 Initiated: March 10, 2021 #Z-1346-2021

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

Details

Units Affected
12 units
Distribution
US Nationwide distribution in the states of FL, MN, OH, PA, TX.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 12 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1346-2021.