Siemens recalls Ysio X.pree digital X-ray systems (model 11107464) due to potential display of previous patient images during image recovery, risking misdiagnosis. Affected units have specific serial numbers.
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
Siemens is recalling its Ysio X.pree digital X-ray systems (model 11107464) because a technical issue could show images from a previous patient instead of the current one during recovery. This might lead to incorrect diagnoses if the system disconnects during the process.
During image recovery, if the system loses connection to the MAX detector, it might show an older patient's image instead of the current one. This could cause misdiagnosis if the healthcare provider uses the incorrect image for treatment decisions.
Healthcare facilities using the Ysio X.pree digital X-ray system with model number 11107464 are affected. Patients undergoing X-rays may be at risk if the system displays the wrong image during recovery.
Check for the model number 11107464 on the Ysio X.pree system. Affected units have specific serial numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045.
Verify if your system has any of the listed serial numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045.
The recall occurs because the system might display an older patient's image instead of the current one during image recovery if the connection to the MAX detector is interrupted, which could lead to misdiagnosis.
Check if your Ysio X.pree system has model number 11107464 and one of the specific serial numbers listed: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045.
The recall does not specify a remedy, so affected users should contact Siemens Medical Solutions USA, Inc directly for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1346-2021 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
