ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM (2020-11-12)

Starting date:

November 12, 2020

Posting date:

November 27, 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-74419

Last updated:
2020-11-27

• 
  Reason
• 
  Affected products

Affected Products

A. ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM

B. ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM

Reason

Stryker has received customer and service tech reports that the Altrix Precision Temperature Management System may experience error code RFU (Remove From Use) 35. This error code will cause the unit to alarm and will prevent further use until the error message is cleared by service personnel.

The RFU 35 message is intended to alert the user to a failure of safety temperature sensors intended to ensure correct water temperature. However, reports have indicated that RFU 35 has occurred without any failure of the safety sensors. This error may be cause by variable flow conditions within the unit.

Affected products