Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging moda
FDA device recall Z-1370-2012 · posted 2012-04-05 · Terminated
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
- Action taken
- Hologic Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides instructions on how to re-review the stored images and correct any annotation defect. A SecurView DX 7.3.0 Confirmation of Notification form was enclosed for customers to complete and return to the firm via fax at 866-652-8674. Contact Hologic's Help Desk at 1-877-371-4372 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 7 units
- Distribution
- Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
- Date initiated
- 2012-02-28
- Date posted
- 2012-04-05
- Date terminated
- 2012-05-07
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECURVIEW DX DIAGNOSTIC WORKSTATION (K103385) | Hologic, Inc. | 2011-02-02 |