Siemens Artis zee Ceiling Recalled for Display Malfunction
Siemens is recalling 73 Artis zee ceiling units because the display may fail to show images after power save mode, potentially requiring procedure 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 (medical device) where the malfunction could lead to procedure cancellation or patient transfer, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 73 Artis zee ceiling units (Material no. 10094137) used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a software issue where the Large Display may remain black without showing an error message after returning from power save mode, even though X-ray functionality remains active.
The defect does not occur during ongoing procedures. If the issue arises, the system cannot be operated normally, which may necessitate canceling or restarting the treatment or transferring the patient to an alternate system. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue or replace the affected units.
The recalled product
- Product
- Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 73
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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