MammoTest Breast Biopsy System.

This recall has been terminated (originally issued January 5, 2005).

Company: Fischer Imaging Corporation
Recall Initiated: July 9, 2004
Posted: January 5, 2005
Terminated: March 13, 2012
Recall Number: Z-0379-05
Quantity: 860 units
Firm Location: Denver, CO
Official Source: View on FDA website ↗

Reason for Recall

X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.

Distribution

Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.