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Terminated

MammoTest Breast Biopsy System.

FDA Recall Z-0379-05 · Posted 2005-01-05

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeIZH
Date Initiated2004-07-09
Date Terminated2012-03-13
Product Quantity860 units

Reason for Recall

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

Firm Action

Consignees were notified by letter on 7/9/2004.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861692FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEMFischer Imaging Corp. · 1986-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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