Interventional fluoroscopic x-ray systems may incorrectly report a high dose
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the reported dose may be overstated rather than understated, with no clinical consequence described in the source.
Plain-English summary
An interventional fluoroscopic x-ray system is being recalled under code 4056869295923. The source does not state a quantity.
According to the manufacturer, in very rare situations communication between the sensor measuring dose applied to the area and the corresponding software fails, and as a result of the failure the system may incorrectly report an application of a high dose. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the code above and follow the instructions issued 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)
- 4056869295923
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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