Elekta Modulator Discharge Rod
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Elekta Infinity | All lots. | 1550358 |
| Elekta Infinity | All lots. | 1552092 |
| Versa HD | All lots. | 1550359 |
| Versa HD | All lots. | 1552093 |
| Harmony | All lots. | 1553032 |
| Elekta Synergy | All lots. | 1550357 |
| Elekta Synergy | All 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
| Elekta Solutions Ab |
| Hagaplan 4, Stockholm, Sweden, 11368 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81238
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