Recall Z-1432-2010 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
| Date | Apr 23, 2010 (initiated Jan 11, 2007) |
| Status | Terminated |
| Reason | In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Iraq, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Russia, Serb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE Elekta Instruments, Inc., Jan 15, 1999 |