Zeus IE Anesthesia Workstation (2014-05-30)

Starting date:

May 30, 2014

Posting date:

June 18, 2014

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-40045

• Reason
• Affected products

Recalled Products

Zeus IE Anesthesia Workstation

Reason

The device is designed to generate an audible and visual alarm when the measured value for spo2 falls below the alarm threshold set for the spo2 low alarm by the clinician. If the measured value continues to fall, the device is designed to continue to generate a spo2 low alarm. But, for devices with software version 1.03, if the sp02 measured value drops below the spo2 low alarm threshold by more than 10 percent, the audible and visual alarm for sp02 low will stop. If the value measured rises again, the alarm will be generated again as soon as the measured value is ten percent or less below the spo2-low alarm threshold. All displayed measurements of values and spo2 curves are performing as designed at any time.

Affected products