Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic di
FDA device recall Z-0538-2011 · posted 2010-12-03 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.
- Action taken
- Elekta, Inc. sent an Important Notice A343 dated October 14, 2010 to all affected consignees. The Notice identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed constantly monitor the patient before and during the treatment. Check the patient's position after every patient movement (e.g. coughing). Advise all appropriate personnel of the content of the notice place a copy of the Notice In the Important Notice Section of the HeadFix User Manual P10103-108. For questions regarding this recall service.schwabmuenchen@elekta.com
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 34 units
- Distribution
- Worldwide Distribution - USA including AZ, CA, CT, FL, GA, IL, KY, MI, MS, NY, NC, OK, OR, RI, TN, TX, VA, WA and the country of Canada
- Date initiated
- 2010-10-14
- Date posted
- 2010-12-03
- Date terminated
- 2010-12-28
- 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 |
|---|---|---|
| HEADFIX (K030439) | Medical Intelligence Medizintechnik GmbH | 2003-05-08 |