Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use
Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.
What this means for you
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: This is an FDA Class II recall involving potential loss of functionality in a critical medical imaging device with no reported injuries or hospitalizations. It represents a risk-of-harm scenario where equipment may become non-functional during clinical use, though injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions is recalling Artis zeego (Model 10280959) and Artis Q.zeego (Model 10848283) interventional fluoroscopic X-ray systems. The recall affects 233 units worldwide, including 32 in the United States distributed across multiple states and countries.
The systems have a potential malfunction where the robotic stand cannot move after startup if the BIOS battery of the stand's control PC becomes discharged. When this condition occurs, all stand movements are blocked and cannot be reactivated without a field service engineer's intervention.
Healthcare facilities using these systems should contact Siemens Medical Solutions immediately for evaluation and service. The manufacturer is implementing a solution to address this issue.
The recalled product
- Product
- Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- equipment-malfunction
- robotic-system-failure
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 (1)
- UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007
Distribution
Distributed nationwide across the United States.
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