Siemens recalls specific MAMMOMAT Revelation models for potential vacuum biopsy system limitation during mammography exams. Affected units may have reduced tube arm movement range, causing difficulties removing the biopsy system.
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Siemens is recalling certain MAMMOMAT Revelation mammography machines due to a limitation in the vacuum biopsy system. If an exam is interrupted while the InSpect Projection View is active, the tube arm's movement range decreases from +/-15 degrees to +/-6 degrees, which could make it harder to remove the biopsy system.
When an examination is interrupted while the InSpect Projection View is active and the vacuum biopsy system is being used, the tube arm's manual movement range decreases from +/-15 degrees to +/-6 degrees. This reduction in movement range may cause difficulties in removing the vacuum biopsy system, potentially affecting the exam's completion.
Medical professionals using the specific MAMMOMAT Revelation models with serial numbers listed in the recall. Patients undergoing mammography exams with these devices may be at risk if the vacuum biopsy system is used during an interrupted exam.
The affected models are the MAMMOMAT Revelation with serial numbers listed in the recall (e.g., 1026, 1057, 1348, etc.). These units were distributed in the US and are intended for mammography exams, screening, diagnostics, biopsies, and dual energy procedures under medical supervision.
Verify if your MAMMOMAT Revelation has a serial number listed in the provided recall list (e.g., 1026, 1057, 1348, etc.).
The vacuum biopsy system may have reduced movement range from +/-15 degrees to +/-6 degrees if an exam is interrupted while the InSpect Projection View is active, potentially making it harder to remove the biopsy system.
The MAMMOMAT Revelation model with serial numbers listed in the recall (e.g., 1026, 1057, 1348, etc.) are affected.
No, the recall does not require immediate discontinuation. The hazard is a potential limitation during specific use scenarios, not a safety risk that requires stopping use.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2388-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2388-2020 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
