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Sapphire Multi-Therapy Infusion and Epidural Infusion Pumps (2015-09-23)
- Starting date:
- September 23, 2015
- Posting date:
- October 14, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55354
Affected Products
Sapphire Multi-Therapy Infusion and Epidural Infusion Pumps
Reason
Q Core Medical has identified a software issue with Q Core Sapphire Multi-Therapy and Epidural Pumps with each of the software version R11V53 change sets 12333, 12334 and 12998 that may create a potential risk of over-delivery in specific situations. No patient injuries or deaths have been reported as a result of this issue. However, Q core has determined there is a significant patient safety risk due to the potential for over-delivery.
Affected products
Sapphire Multi-Therapy Infusion and Epidural Infusion Pumps
Lot or serial number
Not applicable
Model or catalog number
- 15031-000-0001
- 15031-000-0013
- 15032-000-0001
- 15032-000-0011
Companies
- Manufacturer
-
Q Core Medical Ltd.
29 Yad Haruzim St., P.O. Box 8639,
Netanya
4250529
ISRAEL