MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervis
FDA device recall Z-1638-2014 · posted 2014-05-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
- Action taken
- A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 5
- Distribution
- Distributed in the states of GA, FL, NY, NV, and MA.
- Date initiated
- 2014-04-25
- Date posted
- 2014-05-20
- Date terminated
- 2014-12-15
- 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 |