Health product recall

Enterprise 9000x With Indigo Module

Brand(s)
Last updated

Summary

Product
Enterprise 9000x With Indigo Module
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected Products

Lot or serial number

Model or catalog number

Enterprise 9000x With Indigo Module

P0582993
P0592910
P0643750
P0653207

Not Applicable

Issue

Arjo has observed an increasing complaint trend on the following failure modes occurring on Arjo medical beds assembled with the Indigo modules: unanticipated device self-acceleration while being operated by a caregiver, unexpected movement without any intentional activation from a stationary position, device movement in a wrong direction (i.e. backwards instead of forwards and vice versa).

Recall Start Date: August 23, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Physical medicine
Companies

Arjohuntleigh Ab

Hans Michelsensgatan 10, Malmo, Sweden, 21120

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-74242

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