Siemens recalls Mammomat Revelation mammography systems with software version VC10 and Biopsy Option due to rare workstation unresponsiveness during biopsies. Affected units may require software update or repair.
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
Siemens is recalling Mamm: Mammomat Revelation mammography systems with software version VC10 and Biopsy Option. The recall is because the system may become unresponsive during biopsies, which could lead to incomplete procedures or safety issues.
The system's InSpect function can become unresponsive during biopsies, meaning the workstation may not respond to user inputs. This could cause incomplete procedures or safety issues if the system fails during critical operations.
Mammography technicians and patients using Siemens Mammomat Revelation systems with software version VC10 and Biopsy Option for biopsies. Those performing biopsies with this software are most at risk.
Check if your Mammomat Revelation system has software version VC10 with the Biopsy Option. This version was sold for mammography exams, screening, diagnostics, biopsies, and dual energy procedures.
Verify your Mammomat Revelation system's software version and whether the Biopsy Option is installed.
Reach out to Siemens Medical Solutions USA, Inc for guidance on next steps or potential software updates.
No, only those with software version VC10 and Biopsy Option.
Contact Siemens Medical Solutions USA, Inc for specific instructions.
The recall states the workstation may become unresponsive during biopsies, but it does not specify a risk of serious injury.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0160-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0160-2020 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.
