Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and
FDA device recall Z-1251-2011 · posted 2011-02-15 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.
- Action taken
- Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 379 units
- Distribution
- Nationwide
- Date initiated
- 2009-10-02
- Date posted
- 2011-02-15
- Date terminated
- 2011-02-17
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEKSELL STEREOTACTIC SYSTEM (K972324) | Elekta Instrument AB | 1998-03-02 |