Recall Z-0160-2020
Siemens Medical Solutions USA, Inc · initiated July 23, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Codes / lots: software version VC10 and Biopsy Option
Reason for recall
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
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0160-2020
- Initiated
- July 23, 2019
- Terminated
- May 6, 2020
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 139 WW (33 US)
- Distribution
- Nationwide
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA