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Leica Asp6025 Tissue Processor
- Starting date:
- June 2, 2017
- Posting date:
- July 17, 2017
- 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-63960
Reason
The affected devices have incorrect labelling with regard to the specified voltage for the alarm connectors on the rear side of the instrument. The current incorrect labels specify 125VA.C as maximum voltage. It has been identified, that if someone connects such 125VA.C to the 6.3mm stereo jack, there would be hazardous voltage accessible on the plug which could lead in the worst case to a serious electrical incident. In addition, the current specification in the instruction for use (IFU)has an incorrect labelling with regard to the specified voltage for the alarm connectors. The translated IFU’s and the "online help" of the instruments also have an incorrect labelling with regard to the specified voltage of the alarm connectors.
Affected products
Leica Asp6025 Tissue Processor
Lot or serial number
314
316
448
538
594
712
778
Model or catalog number
ASP6025
Companies
- Manufacturer
-
LEICA BIOSYSTEMS NUSSLOCH GMBH
HEIDELBERGER STREET 17-19
NUSSLOCH
69226
GERMANY