PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 8, 2017 Initiated: January 11, 2017 #Z-1118-2017

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

Details

Units Affected
55 units
Distribution
United States Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 55 units.
Why was this product recalled?
Software error
Which agency issued this recall?
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1118-2017.