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 |
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: 2023-09-08
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