Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and
FDA device recall Z-0319-2012 · posted 2011-11-30 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
- Action taken
- Elekta sent an IMPORTANT NOTICE letter dated March 25, 2011 to all affected customers. The letter identified the affected product, the problem, key safety procedures and information to users for safe operation of the Stereotactic Circular Collimator. Elekta will issue a Mandatory Action Field Change Order which will include an updated Circular Collimator Instructions for Use - 102022201 and new labels. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. Also, Elekta is offering some free WebEx sessions which will include the procedures and recommended operation of these types of accessories. Customers are instructed to register at www.elekta.com/SafeAccessories.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 89 devices
- Distribution
- Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
- Date initiated
- 2011-03-25
- Date posted
- 2011-11-30
- Date terminated
- 2012-10-02
- 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 |
|---|---|---|
| 3D LINE STEROTACTIC HARDWARE ACCESSORIES (K011255) | 3D Line USA, Inc. | 2001-12-20 |