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
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