Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Elekta Digital Linear Accelerator

31 Mar 2015

It has come to our attention that medical device manufacturer, Elekta, has identified an unserviceable batch of bolts used to install the counterbalance weight assembly on the gantry drum of Elekta Digital Linear Accelerator [Serial numbers: 152807, 152943, 153060, 153255, 153300, 153348 - 153350, 153359, 153406, 153511, 153530 - 153532, 153534 - 153586, 153588 - 153620, 153622 - 153647, 153649 - 153670, 153672 - 153678, 153680, 153683 - 153685, 153691, 153696, 153699, 153702, 153710, 153712, 153713, 153715, 153717, 153723 - 153728, 153734]

The defective bolts have the mark "OF" on the head. If the bolts have a fault, the gantry drum is not stable. It can fall and cause fatal injuries to users.

The manufacturer will replace all the defective bolts that have the mark "OF" on the head. The manufacturer advises users not to use the digital linear accelerator until the bolts are checked by the manufacturer's representative.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 31 March 2015

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