Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA device recall Z-1072-2013 · posted 2013-04-09 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The Column rotation can accidentally be moved to a different position which in the locked position.
- Action taken
- Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 443
- Distribution
- Nationwide Distribution and Puerto Rico.
- Date initiated
- 2013-03-14
- Date posted
- 2013-04-09
- Date terminated
- 2015-03-17
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (K983678) | Elekta Instruments, Inc. | 1999-01-15 |