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TCM4 Series Base Unit
- Starting date:
- November 27, 2012
- Posting date:
- January 7, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16531
Recalled Products
A. TCM4 Series Base Unit
Reason
As reported to Radiometer Medical APS, there is a potential risk of receiving an electrical shock under certain conditions. TCM4 series base unit does not comply with IEC 60601-1, 2nd edition, subclause 15(b).
Affected products
A. TCM4 Series Base Unit
Lot or serial number
000-154, 391-876, 391-878, 391-880, 910-246, Serial Numbers below R0175N009
Model or catalog number
000-154, 391-876, 391-878, 391-880, Power Supply 910-246
Companies
- Manufacturer
- Radiometer Medical APS