Siemens Artis zee floor recall due to display failure
Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation.
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-harm product where the display failure may require treatment cancellation or patient transfer, but no injuries or illnesses have been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 14 Artis zee floor systems (Material no. 10094135) used for angiography and whole body radiographic/fluoroscopic procedures. The recall covers units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall is issued because the Large Display may fail to show an image and remain black without displaying an error message after returning from power save mode, even though X-ray capability remains active. This issue does not occur during ongoing procedures. If the problem arises, the system cannot be operated normally, which may necessitate canceling or restarting the treatment or transferring the patient to an alternate system.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the affected units.
The recalled product
- Product
- Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 14
Distribution
Part of a larger recall action
This product is one of 12 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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