Siemens Biograph mCT X-4R Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling two Biograph mCT X-4R systems because they may be missing a locking ring on optional ceiling mounts.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling two units of the Biograph mCT X-4R, Model Number 10248670. The recall is due to a defect where the emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
The affected units have serial numbers 1009 and 11061. These products were distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland.
Healthcare facilities should contact Siemens Medical Solutions USA Inc. for instructions on how to resolve the issue. Consumers should not use the affected equipment until the defect is corrected.
The recalled product
- Product
- Biograph mCT X-4R, Model Number 10248670
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 2
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 (2)
- SERIAL NUMBERS: 1009
- 11061
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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