MLCi/MCLi2. Radiation therapy.
FDA device recall Z-1651-2012 · posted 2012-05-23 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The Y2 diaphragm block was found loose.
- Action taken
- Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 386
- Distribution
- Nationwide Distribution including Puerto Rico.
- Date initiated
- 2012-04-19
- Date posted
- 2012-05-23
- 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 |
|---|---|---|
| MLCI2 (K082122) | Elekta , Ltd. | 2008-08-29 |