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Mammomat Inspiration Mammography System with Stereostatic/Biopsy Device (2014-09-22)
- Starting date:
- September 22, 2014
- Posting date:
- October 1, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41599
Recalled Products
Mammomat Inspiration Mammography System with Stereostatic/Biopsy Device
Reason
The stereo biopsy devices (serial numbers 2000 through 2090) 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 inserted, it could lead to an unintentional patient injury.
Affected products
Mammomat Inspiration Mammography System with Stereostatic/Biopsy Device
Lot or serial number
10140000-1146
10140000-2042
Model or catalog number
10501331
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY