Siemens Ysio MAX Radiographic Systems Recalled for Cable Failure Risk
Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that could cause the equipment to drop unexpectedly, posing a significant risk of injury to patients or staff, which aligns with the criteria for a Severe (Score 4) classification.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 31 Ysio MAX radiographic systems (model number 10762470) equipped with Tube stand 3D V (model number 7042018 or 7042034). These systems are used for radiographic and tomographic exposures of the whole body.
The recall is due to a defect where the steel cables inside the lifting column of the overhead tube may rupture in rare cases of high clinical workload without triggering the safety lock. This failure can overload the safety rope, which is not designed for continuous load, leading to mechanical fatigue and causing the arm to drop down unexpectedly during vertical movement or patient positioning.
The affected products were distributed to hospitals and facilities in 38 US states and the District of Columbia. Siemens has provided a list of specific serial numbers for the 31 units involved. Healthcare facilities should contact Siemens to arrange for the necessary corrective actions.
The recalled product
- Product
- Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 31
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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