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