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Health product recall

Medi-Therm Hyper/Hyperthermia Machine (2014-02-06)

Starting date:
February 6, 2014
Posting date:
March 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-38343

Recalled Products

Medi-Therm Hyper/Hyperthermia Machine

Reason

Stryker Medical has identified that on some units of the device, there is a lack of a water temperature display while the unit is in auto mode. While in auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during auto mode. If the user wants to see the water temperature displayed and switches out of auto mode to manual mode, then back to auto mode, the therapy will be reset, and may potentially cause patients to reach the set point earlier.

Affected products

Medi-Therm Hyper/Hyperthermia Machine

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

MTA7900

Companies
Manufacturer
Stryker Medical
3800 E Center Avenue
Portage
49002
Michigan
UNITED STATES