Recall Z-1514-2014 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
| Date | Apr 25, 2014 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | If screws are not properly tightened with a torque wrench they may become loose over time. |
| Root cause | Component design/selection |
| Action | Corrective Action #1 - Important Field Safety Notice 618 01 302 002 was issued April 2014. The Notice informs end users about the problem and the potential clinical impact. It also give a recommendation how the risk can be mitigated - inspect the screws and if loose contact Elekta Service to tighten the screws with 20 Nm. The notice also advises the customer that a modification kit will be released that introduces an improved screw solution. The solution will be implemented on all affected products when available. Corrective Action #2 Permanent Solution - Replace Current Screws - An impro |
| Quantity | 266 |
| Distribution | Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072898 | HEXAPOD EVO RT COUCH TOP Medical Intelligence Medizintechnik GmbH, Oct 25, 2007 |