Siemens Mammomat Revelation Recall for Biopsy Software Error
Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.
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 explicitly states the issue occurs in 'rare cases' and does not report any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 139 Mammomat Revelation mammography systems worldwide, including 33 units in the United States. The affected units are equipped with software version VC10 and the Biopsy Option. These devices are intended for mammography exams, screening, diagnostics, biopsies, and dual energy procedures.
The recall is due to a software error that can occur when performing a biopsy using the InSpect function. In rare cases, the acquisition workstation may become unresponsive to normal user interaction. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The recall is distributed nationwide.
The recalled product
- Product
- Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
- Manufacturer
- Siemens Medical Solutions USA, Inc
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)
- software version VC10 and Biopsy Option
Distribution
Distributed nationwide across the United States.
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