Z-1118-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- January 11, 2017
- Termination Date
- November 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for 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.
Reason for Recall
Software error
Distribution Pattern
United States Nationwide Distribution
Code Information
Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560 6524 6412 6442 5018 6675 8038 6575 6045 3122 6871 3243 4571 6259 6469 6676 6474 6640 6452 6561 6801 2098 4161 6483 6344 6288 6594 8002 6610 6394 4018 6502 6080 4214 6893 6093 3118 6601 5042 6246 3088 4525 6870