Siemens Modularis VarioStar Lithotripter Recalled for Display Freeze Issue
Siemens Medical Solutions is recalling 15 Modularis VarioStar lithotripters because a display freeze prevents current treatment data from being shown to users.
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. The hazard is a functional defect (display freeze) that prevents data visualization, which fits the criteria for a moderate severity issue without reported adverse health consequences.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 units of the Modularis VarioStar lithotripter, a medical device designed to treat urolithiasis (kidney stones). The recall is due to a display freeze on the MODULARIS hand control that results in information not being updated on the display. Consequently, current treatment data is not shown to the user during operation.
The affected devices, identified by model number 1157200, were distributed in Puerto Rico and the states of Missouri, North Carolina, Georgia, Mississippi, Louisiana, and Kentucky. The source text does not specify specific hospital names or installation dates.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the display issue. The source text does not provide specific contact details or remediation steps beyond the recall notice itself.
The recalled product
- Product
- MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Lithotripter
- Affected units
- 15
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)
- model# 1157200
Distribution
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