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Health product recall

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