Siemens Ysio Max X-Ray System Recalled for Software Defects
Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.
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 is classified as FDA Class II and involves a risk of collision with persons or obstacles, which constitutes a significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 512 units of the SIEMENS Healthineers Ysio Max Interventional Fluoroscopic X-Ray System (Model 10762470). The recall is due to two software issues affecting the device. The systems were distributed nationwide in the United States.
The first issue involves the use of an override function for blocked system movements, which may cause the system to collide with obstacles or persons under operator control. The second issue involves incorrectly assigned images caused by the detector MAX Static, which may result in an incorrect base for diagnosis. The recall also affects Luminos dRF Max, Luminos Agile Max, and Uroskop Omnia Max systems regarding the first issue, and Luminos dRF Max and Luminos Agile Max systems regarding the second issue.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve these software issues. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 512
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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