Siemens MAMMOMAT Revelation Mammography System Recalled for Biopsy Removal Limitation
Siemens is recalling MAMMOMAT Revelation mammography systems because a software limitation may make it difficult to remove the vacuum biopsy system if an exam is interrupted.
What this means for you
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 involves a medical device with a functional limitation that may impede the removal of a biopsy system, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the MAMMOMAT Revelation mammography system, model no. 11343300. The recall involves 230 units worldwide, including 64 units distributed in the United States. These devices are intended for mammography exams, screening, diagnostics, biopsies, and dual energy procedures under the supervision of medical professionals.
The recall is due to a limitation in the tube arm's manual movement range. If an examination is interrupted while the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the manual movement range decreases from +/-15 degrees to +/- 6 degrees. This limitation may lead to difficulties in removing the vacuum biopsy system.
Healthcare facilities that have purchased or received these devices should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue. The recall number is Z-2388-2020.
The recalled product
- Product
- MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10