Public recall detail

Elekta Modulator Discharge Rod

2025-11-19

medium
Recall Safety notice
Quick summary

Quick summary: Elekta Modulator Discharge Rod. Date: 2025-11-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Elekta Modulator Discharge Rod. Date: 2025-11-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandElekta Solutions Ab
ProductElekta Modulator Discharge Rod
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81238

Affected products

ProductElekta Infinity
LotAll lots.
Model1550358
Serial numberAll lots.
DescriptionElekta Infinity
ProductElekta Infinity
LotAll lots.
Model1552092
Serial numberAll lots.
DescriptionElekta Infinity
ProductVersa HD
LotAll lots.
Model1550359
Serial numberAll lots.
DescriptionVersa HD
ProductVersa HD
LotAll lots.
Model1552093
Serial numberAll lots.
DescriptionVersa HD
ProductHarmony
LotAll lots.
Model1553032
Serial numberAll lots.
DescriptionHarmony
ProductElekta Synergy
LotAll lots.
Model1550357
Serial numberAll lots.
DescriptionElekta Synergy
ProductElekta Synergy
LotAll lots.
Model1550291
Serial numberAll lots.
DescriptionElekta Synergy

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.

What you should do

  • Elekta will issue an IFSM to check and replace faulty discharge rod crimps as needed. A service representative will contact users.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesElekta Solutions Ab Hagaplan 4, Stockholm, Sweden, 11368
Recall date2025-11-14
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81238
Background{}
CompaniesElekta Solutions Ab Hagaplan 4, Stockholm, Sweden, 11368
AudiencesHealthcare
Source updated2025-11-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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