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

• Reason
• Affected products

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