Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplast
FDA device recall Z-1159-2010 · posted 2010-03-18 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Customer reported larger than expected variations in wedge factory with gantry rotation.
- Action taken
- Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 315 units
- Distribution
- United States, Canada and Mexico.
- Date initiated
- 2005-10-01
- Date posted
- 2010-03-18
- Date terminated
- 2010-03-25
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA SYNERGY SYSTEM (K032996) | Elekta Oncology Systems, Ltd. | 2003-10-23 |