Public recall detail

Trexo Home and Trexo Plus

2023-08-24

medium
Recall Safety notice
Quick summary

Quick summary: Trexo Home and Trexo Plus. Date: 2023-08-24.

Recommended action

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

Recall details

Quick summary: Trexo Home and Trexo Plus. Date: 2023-08-24.

Official details

Affected product details

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

BrandTrexo Robotics Inc.
ProductTrexo Home and Trexo Plus
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74192

Affected products

ProductTrexo Home
LotMore than 10 numbers, contact manufacturer.
ModelA0001
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTrexo Home
ProductTrexo Plus
LotMore than 10 numbers, contact manufacturer.
ModelA0001
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTrexo Plus

Issue

The following malfunctions and nonconformances were observed during Trexo lab-testing and Trexo design reviews of the device, Resulting in this voluntary device recall and proposed field correction. Electromagnetic (EM) radiation levels above threshold (Ref: IEC 60601-1-11), as observed during lab-testing contracted by Trexo. Water ingress was observed within electronics enclosures after IP22 testing, as observed during lab-testing contracted by Trexo. Recall start date: July 31, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - Physical medicine
CompaniesTrexo Robotics Inc. 6705 Milcreek Drive, Mississauga, Ontario, Canada, L5N 5M4
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74192
Background{}
CompaniesTrexo Robotics Inc. 6705 Milcreek Drive, Mississauga, Ontario, Canada, L5N 5M4
AudiencesGeneral public
Source updated2023-08-24

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

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