Health product recall

HemoSphere Oximetry Cable (2020-10-08)

Starting date:
October 8, 2020
Posting date:
October 23, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74155



Last updated:
2020-10-22

Affected Products

HemoSphere Oximetry Cable

Reason

This issue involves oximetry smart cables that are exhibiting excessive heating when in use. The overheating may cause an oximetry cable malfunction fault/error message and has the potential to stop producing oximetry values. Although there have been complaints of the cable being warm to the touch, there have been no patient injuries noted to date. This non-conformance may cause a delay in the procedure while the product is exchanged.

Affected products

HemoSphere Oximetry Cable

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

HEMOXSC100

Companies
Manufacturer

Edwards Lifesciences LLC

1 Edwards Way

Irvine

92614

California

UNITED STATES