CanadaThe Elekta Modulator Discharge Rod used with Elekta Infinity (models 1550358, 1552092), Versa HD (1550359, 1552093), Harmony (1553032) and Elekta Synergy (1550357, 1550291) is affected; all lots are listed. Elekta found the supplier had assembled the crimp in reverse so the earth lead on the safety discharge rod can be pulled out with minimal force, posing potential safety risks to the field service engineer. Elekta will issue an IFSM to check and replace faulty crimps as needed and a service representative will contact users.
What's being recalled
Companies: Elekta Solutions Ab, Hagaplan 4, Stockholm, Sweden, 11368.
How to identify it
Affected products: Elekta Infinity; Lot or serial number: All lots.; Model or catalogue number: 1550358
Affected products: Elekta Infinity; Lot or serial number: All lots.; Model or catalogue number: 1552092
Affected products: Versa HD; Lot or serial number: All lots.; Model or catalogue number: 1550359
Affected products: Versa HD; Lot or serial number: All lots.; Model or catalogue number: 1552093
Affected products: Harmony; Lot or serial number: All lots.; Model or catalogue number: 1553032
Affected products: Elekta Synergy; Lot or serial number: All lots.; Model or catalogue number: 1550357
Affected products: Elekta Synergy; Lot or serial number: All lots.; Model or catalogue number: 1550291
The hazard
Elekta has identified a safety concern related to the modulator discharge rod. It was discovered that the supplier had been incorrectly assembling the crimp within the crimping tool - fitting it in reverse. As a result, the earth lead on the safety discharge rod was able to be pulled out with minimal force, which could pose potential safety risks to the field service engineer. While not all crimps are affected, reversed crimps were found in stock at Elekta.
What to do
Elekta will issue an IFSM to check and replace faulty discharge rod crimps as needed. A service representative will contact users.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States