Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch
Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a software error could lead to misdiagnosis, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 12 units of the Ysio X.pree digital X-ray system (Model Number: 11107464). These systems are used to generate X-ray images of the whole body, including the skull, chest, abdomen, and extremities. The recall involves specific serial numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, and 10045.
The recall is due to a software issue during the image recovery process. If the connection to a MAX detector is interrupted while image recovery is initiated, the system may display a previously acquired image—potentially belonging to a different patient—instead of the currently acquired image. This error could potentially impact the diagnosis of the patient being examined.
The affected units were distributed nationwide in the United States, specifically in Florida, Minnesota, Ohio, Pennsylvania, and Texas. Healthcare facilities using these devices should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the issue.
The recalled product
- 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 12
Distribution
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