Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk
Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
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 physical injury to patients, but the source text explicitly states the risk is 'unlikely' and no injuries have been reported, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 Ysio Max radiographic systems distributed nationwide in the United States. The Ysio Max is a medical device used in hospitals, clinics, and medical practices for radiographic and tomographic exposures of the whole body, including the skull, chest, abdomen, and extremities.
The recall is due to a potential issue with the patient table where an internal part may detach. This detachment could cause the table top to tilt to the left side, creating an unlikely risk of injury to a patient on the table. The affected systems are identified by specific model and serial numbers listed in the recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue with the patient table. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- YSIO Max Product Usage: 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 37
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 (20)
- Model Number: 10762470
- 10893300
- 10746665 Serial Numbers: 24644
- 24613
- 24615
- 40328
- 24611
- 24612
- 24614
- 40326
- 40322
- 40316
- 24599
- 24600
- 40404
- 24634
- 2464124590
- 40402
- 1314
- 40312
Distribution
Distributed nationwide across the United States.
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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