Agency classClass IIOur severity:High FDA (Devices)·Z-1346-2021·Announced 2021-04-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Diagnostic Imaging
Hazard: mis-diagnosis
software-error
Affected units: 12

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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