Siemens Medical Solutions USA, Inc Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075
Siemens Medical Solutions USA, Inc is recalling Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. due to Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images ma. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
ID, IL, MI, MN, MO, ND, PA
Page updated: Jan 11, 2026