Siemens Biograph 64-4R CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions USA Inc. is recalling two Biograph 64-4R CT 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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a missing component (locking ring) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling two units of the Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302. The recall involves serial numbers 1041 and 1042. These emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
The affected units were distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland. The missing locking ring on the optional ceiling mounts presents a potential safety hazard.
Healthcare facilities and users of these specific serial numbers should contact Siemens Medical Solutions USA Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
- 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: 1041
- 1042
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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