Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, scr
FDA device recall Z-0086-2015 · posted 2014-10-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i
- Action taken
- A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 3
- Distribution
- US Distribution in states of: NY, VA, and MA.
- Date initiated
- 2014-09-18
- Date posted
- 2014-10-17
- Date terminated
- 2015-02-24
- 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 |