Siemens Combi Dockable Neurosurgery Table Recalled for Height Drop Risk
Siemens Medical Solutions is recalling three Combi Dockable Neurosurgery tables for MRI systems due to a potential manufacturing error that could cause a sudden drop in table height.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sudden drop in table height) where no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Combi Dockable Neurosurgery table designed for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems. The recall is being conducted due to a potential manufacturing error that creates a rare possibility of a sudden drop in table height.
Three systems were distributed in the United States to facilities in the District of Columbia and Maryland. The affected units are identified by Model Numbers 10684336 and 10684337, and Serial Numbers 12811002, 12811003, and 12811017.
The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI Table
- Hazard
- 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 (2)
- Model Number: 10684336
- 10684337 Serial Number: 12811002 12811003 12811017
Distribution
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