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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