MammoTest Breast Biopsy System.
FDA device recall Z-0379-05 · posted 2005-01-05 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
- Action taken
- Consignees were notified by letter on 7/9/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZH
- Quantity affected
- 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, Po
- Date initiated
- 2004-07-09
- Date posted
- 2005-01-05
- Date terminated
- 2012-03-13
- Location
- Denver, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM (K861692) | Fischer Imaging Corp. | 1986-12-15 |