Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
FDA Recall Z-1432-2010 · Posted 2010-04-23
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeJAI
Date Initiated2007-01-11
Date Terminated2010-12-28
Product Quantity185 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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, Serbia, Spain, Sudan, Sweden, Taiwan, Thailand, Turkey & United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.