Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure
Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.
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: This is an FDA Class II recall involving a medical device with a risk of harm—inaccurate dose reporting in x-ray systems could lead to patient injury through under- or over-exposure to radiation. No illnesses or injuries are reported in the source text, and the source explicitly characterizes the communication failure as "very rare," placing it at the High (3) level rather than Severe.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling interventional fluoroscopic x-ray systems (model code 4056869063317) distributed worldwide due to a potential communication failure between the dose-measuring sensor and the system's software.
In rare situations, this communication failure can cause the system to incorrectly report that a high dose of radiation has been applied to a patient. When the sensor and software fail to communicate properly, the system may display inaccurate dose information.
Users should contact Siemens Medical Solutions USA, Inc. for guidance on inspecting and updating affected systems. Healthcare facilities operating these devices should verify proper dose reporting functionality and implement any corrective actions recommended by the manufacturer.
The recalled product
- Product
- interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
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)
- 4056869063317
Distribution
Distribution scope not specified by the agency.
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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