Radionics Head and Neck Localilizer (HNL), Version B
FDA device recall Z-1020-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Radionics, Inc.
- Reason for recall
- Software may provide inaccurate coordinates and cause mistreatment
- Action taken
- Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 4
- Distribution
- Canada, Germany, Greece
- Date initiated
- 2004-05-25
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-28
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL (K991237) | Radionics, Inc. | 1999-08-30 |