Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy an
FDA device recall Z-1432-2010 · posted 2010-04-23 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.
- Action taken
- Mandatory Field Change Order (FCO) 528 053 "Check for zinc plated Precise Table 'Z' mechanism fixation bolts", dated 1/11/2007 was distributed to all affected customers. The Change Order identified the product, stated the reason for the FCO, and the procedure to check and resolve the problem identified.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 185 units
- Distribution
- Worldwide Distribution -- USA, Puerto Rico, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Ira
- Date initiated
- 2007-01-11
- Date posted
- 2010-04-23
- Date terminated
- 2010-12-28
- 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 |