Health product recall

Enterprise 9000x With Indigo Module

Brand(s)
Last updated

Summary

Product
Enterprise 9000x With Indigo Module
Issue
Medical devices - Performance
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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe