Health product recall

Rheo Knee and Rheo Knee XC

Brand(s)
Last updated

Summary

Product
Rheo Knee and Rheo Knee XC
Issue
Medical devices - Performance issue
What to do

Follow instructions on update to firmware.

Affected products

Affected products

Lot or serial number

Model or catalogue number

Rheo Knee

Serial # HF383223
Serial # HF383277
Serial # HF383293
Serial # HF383324
Serial # HF383446
Serial # HF383265
Serial # HF383354
Serial # HF383386
Serial # HF383323
Serial # HF383484
Serial # HF374039

RKN130003
RKN130002
RKN130005

Rheo Knee XC

Serial # HF366536
Serial # HF363325
Serial # HF362173

RKNXC0002
RKNXC0005
RKNXC0003

Issue

In October 2023 a defect was identified in firmware version BRK3.02.17 which is causing unintended device warnings. In some cases, the warnings trigger device shutdown.  Depending on how the user responds to the warnings, the user may experience loss of support which could lead to a fall and potential injury.

Recall start date: March 27, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Physical medicine
Companies
Ossur Hf
Grjothals 1-5, Reykjavik, Iceland, 110
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-75400

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