Siemens Biograph 6-4R CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling specific Biograph 6-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, and the hazard is a missing component rather than a high-risk pathogen or structural vehicle defect, fitting the Moderate criteria for a precautionary recall without reported harm.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling one unit of the Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290, with serial number 45590. The recall is due to a defect where the emission computed tomography system or computed tomography xray system with an optional ceiling mount may be missing a locking ring.
The affected unit was distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. The source text does not specify the number of units affected beyond the single unit identified by serial number, nor does it report any injuries or illnesses associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA Inc. for further instructions regarding the recall and repair of the missing locking ring.
The recalled product
- Product
- Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- 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 (1)
- SERIAL NUMBER 45590
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 8 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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