Altrix Precision Temperature Management System (2018-09-04)

Starting date:

September 4, 2018

Posting date:

September 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67830

• 
  Reason
• 
  Affected products

Affected products

Altrix Precision Temperature Management System

Reason

1. Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5 degrees Celsius while in automatic mode.
2. Users may experience a remove from use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.
3. Users may experience code RFU 27fault condition relating to mechanical interference between the device fan and filter.

Affected products