Siemens Biograph mCT Flow Edge-4R Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling three Biograph mCT Flow Edge-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, but the source text does not report any hospitalizations, injuries, or deaths, nor does it explicitly describe the hazard as a high-risk pathogen or common allergen mislabeling. It is a mechanical defect without reported harm, fitting the Moderate category for low-risk or voluntary precautionary issues.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling three units of the Biograph mCT Flow Edge-4R, Model Number 10528955. 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 were distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. The specific serial numbers for the recalled units are 11002, 11005, and 1008.
This recall is classified as Class II by the U.S. Food and Drug Administration. No specific instructions for consumers are provided in the source text, but the defect involves a missing safety component on the equipment's mounting hardware.
The recalled product
- Product
- Biograph mCT Flow Edge-4R, Model Number 10528955
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Affected units
- 3
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)
- SERIAL NUMBERS: 11002
- 11005
- 1008
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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