Health product recall

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

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

A. ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

8001-000-003

Companies
Manufacturer

Stryker Medical

3800 E Centre Avenue

Portage

49002

Michigan

UNITED STATES

B. ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

8001-000-001
8001-000-015

Companies
Manufacturer

Stryker Medical

3800 E Centre Avenue

Portage

49002

Michigan

UNITED STATES