Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stere
FDA device recall Z-0312-2012 · posted 2011-11-30 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.
- Action taken
- Elekta sent an IMPORTANT NOTICE: Urgent Field Safety Notice letter dated May 12, 2011 to affected customers. The notice identified the affected product, problem, and actions to be taken by the user. The letter describes special care to be used in operating the helmet changer actuator LMR03. The letter states that Elekta will replace all actuators LMRO3. For more details contact your local Elekta representative. .
- Root cause
- Pending
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 44
- Distribution
- Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico
- Date initiated
- 2011-05-26
- Date posted
- 2011-11-30
- Date terminated
- 2014-10-06
- 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 GAMMA KNIFE TARGET SYSTEM, MODEL 24001 (K984328) | Elekta Instrument AB | 1999-05-21 |