Health product recall

Sara Plus

Brand(s)
Last updated

Summary

Product
Sara Plus
Issue
Medical devices - Increased risk or new adverse events
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Sara Plus

More than 10 numbers, contact manufacturer.

HEP1001-US, HEP0001-US

Issue

Since Nov, 2020, Arjo has become aware of 2 customer complaints on smoke and flames coming out of the lift. In both events the extent of flames was limited to the lift and no health consequences were reported. The product (devices and spare parts shipped between Oct 2016 - Jan 2022) in the market are recognized as potentially affected with the risk of cover ignition. The investigation has revealed that the failure is attributed to the insufficient design of Sara Plus PCB that is prone to damage during use.

Recall start date: Mar 28, 2022

Additional information

Details
Original published date: 2022-04-07
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Arjohuntleigh Ab

Hans Michelsensgatan 10, Malmo

Sweden, 21120

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64046