MAMMOMAT Inspiration systems recalled because operator tables shipped with bus-installation kits
Siemens Medical Solutions USA is recalling 6 MAMMOMAT Inspiration systems because operator tables were sold together with a bus-installation kit they are not released for.
What this means for you
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 Inspiration is being recalled. The record lists model number 10140000, UDI-DI 04056869009063, and system serial numbers 6734, 6694, 10121, 10309, 10336 and 10342.
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 6 units, of which 3 are in the United States and 3 outside it. 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 Inspiration;
- 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 (8)
- Model Number: 10140000
- UDI-DI: 04056869009063
- System Serial Numbers: 6734
- 6694
- 10121
- 10309
- 10336
- 10342
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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