Siemens Ysio Systems Recalled for Potential Unintended Radiation Release
Siemens is recalling 433 Ysio radiographic systems because excessive cleaning liquid usage may cause a short circuit, leading to unintended radiation release.
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 unintended radiation release, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 433 units of the Siemens Ysio System, a radiographic system used in hospitals, clinics, and medical practices for whole-body imaging. The recall is due to a potential hazard where excessive usage of cleaning liquid may cause infiltration of the generator console. This infiltration may lead to a short circuit, which could result in an unintended release of radiation.
The affected units are Model nos. 10281013 and 10281163, distributed nationwide in the United States. The source text does not specify a date for the recall or report any injuries or illnesses associated with this defect.
Healthcare facilities should stop using the affected Ysio systems and contact Siemens Medical Solutions USA, Inc. for instructions on how to proceed with the recall and remediation.
The recalled product
- Product
- Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 433
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model nos. 10281013
Distribution
Distributed nationwide across the United States.
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