Recall Monitor
Health Products

Elekta Modulator Discharge Rod

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Elekta Modulator Discharge Rod
Issue: Medical devices - Performance
What to do: Elekta will issue an IFSM to check and replace faulty discharge rod crimps as needed. A service representative will contact users.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Elekta InfinityAll lots.1550358
Elekta InfinityAll lots.1552092
Versa HDAll lots.1550359
Versa HDAll lots.1552093
HarmonyAll lots.1553032
Elekta SynergyAll lots.1550357
Elekta SynergyAll lots.1550291

Issue

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.

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