Recalls / —
—#175517
Product
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
- FDA product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K173408
- Affected lot / code info
- software version VC10 and Biopsy Option
Why it was recalled
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
Root cause (FDA determination)
Software design
Action the firm took
Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-07-23
- Terminated
- 2020-05-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #175517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.