Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the
FDA device recall Z-0523-2015 · posted 2014-12-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 3
- Distribution
- US Nationwide Distribution in the state of: WV, NY, and FL..
- Date initiated
- 2014-10-28
- Date posted
- 2014-12-06
- Date terminated
- 2015-07-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAMMOMAL INSPIRATION (K122286) | Siemens Medical Solutions USA, Inc. | 2013-02-22 |