MAMMOMAT Fusion system recalled because an operator table shipped with a bus-installation kit
Siemens Medical Solutions USA is recalling one MAMMOMAT Fusion system because an operator table was sold together with a bus-installation kit it is not released for.
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: Scored 2 because the record cites a component supplied outside its released installation type, with no stated consequence or reported harm.
Plain-English summary
The Siemens MAMMOMAT Fusion is being recalled. The record lists model number 10140000, UDI-DI 04056869009063, and system serial number 10559.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations, as it was designed for stationary operation only.
The record lists 1 unit, outside the United States only. Distribution was worldwide, covering Arkansas, California and New York domestically and Australia, Canada and India internationally. The FDA has classified the action as Class II.
The record describes a component supplied for an installation type it was not released for, and states no injuries. Facilities should follow Siemens' instructions.
The recalled product
- Product
- MAMMOMAT Fusion;
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1
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 (3)
- Model Number: 10140000
- UDI-DI: 04056869009063
- System Serial Numbers: 10559
Distribution
Part of a larger recall action
This product is one of 3 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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