Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement
Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.
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 is classified as FDA Class II and involves a risk-of-harm product (unexpected mechanical movement) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 81 units of the Ysio stationary X-Ray system (model no. 10281013) in the United States. The recall affects 308 units worldwide. The affected units were distributed nationwide in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, and WI.
The recall is due to a defect where the system may process incorrect internal values for the position of its ceiling tube stand. If a user activates longitudinal or transversal stand movement using the buttons at the tube head or the remote console, the system's controls may initiate an unintended correction of the tube stand position. This can result in unexpected movement of the equipment.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
Distribution
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