Recall Z-1651-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MLCi/MCLi2. Radiation therapy.
| Date | May 23, 2012 (initiated Apr 19, 2012) |
| Status | Terminated |
| Reason | The Y2 diaphragm block was found loose. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 386 |
| Distribution | Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082122 | MLCI2 Elekta , Ltd., Aug 29, 2008 |