Recall Z-0523-2015
Siemens Medical Solutions USA, Inc · initiated October 28, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Codes / lots: model number: 10140000
Reason for recall
It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
FDA-determined cause: Use error
Action taken
A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.
Details
- Recall number
- Z-0523-2015
- Initiated
- October 28, 2014
- Posted by FDA
- December 6, 2014
- Terminated
- July 20, 2015
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 3
- Distribution
- US Nationwide Distribution in the state of: WV, NY, and FL..
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA