Sapphire Infusion Pump
Brand(s)
Last updated
Summary
Product
Sapphire Infusion Pump
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Sapphire Epidural |
Software16.10.1 |
15032-000-0001 |
Sapphire™ Multi-Therapy |
Software 16.10.2 |
15031-000-0032 |
Issue
Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm has been reported due to this issue.
Recall start Date: September 22, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Eitan Medical Ltd.
29 Yad Haruzim St., Netanya, Israel, 4250529
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74340
Get notified
Receive notifications for new and updated recalls and alerts by category.