FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: MammoTest Breast Biopsy System.
- Recall number
- Z-0379-05
- Recalling firm
- Fischer Imaging Corporation
- Product
- MammoTest Breast Biopsy System.
- Status
- Terminated
- Initiated
- 2004-07-09
- Posted
- 2005-01-05
- Terminated
- 2012-03-13
- Reason
- X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
- Root cause
- Other
- Action
- Consignees were notified by letter on 7/9/2004.
- Quantity
- 860 units
- 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.
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K861692"]
- PMA numbers
- not on file
- Product code
- IZH
- Firm FEI
- 1418957
- Firm city
- Denver
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28