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Test Tube Heater Power Supply Component (2014-09-11)
- Starting date:
- September 11, 2014
- Posting date:
- October 14, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41785
Recalled Products
Test Tube Heater Power Supply Component
Reason
The combination of the test tube heater (K-FTH-1012) and power supply (K-APS-300) was recently re-tested for a proposed design change and found to exceed the limits for radiated emissions, and is therefore no longer compliant with IEC60601-1-2: 2007 (Medical Electrical Equipment - part 1-2 Basic Safety and Essential Performance - Collateral Standard). The radiated RF emissions of the K-APS-300 power supply exceed the limits given in CISPR11 Group 1 Class B by up to 6.3 dBuV/m at three metres with very broad peaks occurring at about 85-90MHz and 150MHz.
Affected products
Test Tube Heater Power Supply Component
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K-FTH-1012
Companies
- Manufacturer
-
William A. Cook Australia, Pty. Ltd.,
95 Brandl Street,
Eight Mile Plains, Queensland,
4113
AUSTRALIA