Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning
FDA device recall Z-1030-2011 · posted 2011-02-03 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Possible error in the table longitudinal position.
- Action taken
- Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout. Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites. For questions regarding this recall call 770-670-2548.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 597 units
- Distribution
- Nationwide Distribution and Puerto Rico
- Date initiated
- 2008-03-10
- Date posted
- 2011-02-03
- Date terminated
- 2012-08-09
- 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 |
|---|---|---|
| ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (K983678) | Elekta Instruments, Inc. | 1999-01-15 |