Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical d
FDA device recall Z-0138-2014 · posted 2013-11-04 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Potential for clinical errors.
- Action taken
- Elekta sent an Important Field Safety Notice dated 7/2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the issue and recommendation to resolve either by upgrading their system or to discontinue a clinical use of the device. For further questions please call ( 770 ) 300-9725.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 89
- Distribution
- Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.
- Date initiated
- 2013-07-23
- Date posted
- 2013-11-04
- Date terminated
- 2014-11-18
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3D LINE STEROTACTIC HARDWARE ACCESSORIES (K011255) | 3D Line USA, Inc. | 2001-12-20 |