LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25
FDA device recall Z-0079-2013 · posted 2012-10-18 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
- Action taken
- Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 19, 716 total all units
- Distribution
- Distributed in Brazil, Portugal and Hong Kong.
- Date initiated
- 2012-09-17
- Date posted
- 2012-10-18
- Date terminated
- 2013-07-17
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVEEN NEEDLE ELECTRODE (K982556) | Radiotherapeutics Corp. | 2000-04-06 |
| LEVEEN NEEDLE ELECTRODE (K000032) | Radiotherapeutics Corp. | 2000-03-30 |