Health product recall

HistoCore SPECTRA ST Stainer (2018-05-29)

Starting date:
May 29, 2018
Posting date:
July 27, 2018
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-67296

Affected products

HistoCore SPECTRA ST Stainer

Reason

The affected HistoCore SPECTRA ST Stainers have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.

Though the probability of this fault is low, safety standard ISO61010-1 does require a 2 layer safety level. Corrective actions are required to prevent this error from occurring and to ensure the 2 layer safety level is established.

Affected products

HistoCore SPECTRA ST Stainer

Lot or serial number

148

Model or catalog number

Not applicable

Companies
Manufacturer
LEICA BIOSYSTEMS NUSSLOCH GMBH
HEIDELBERGER STREET 17-19
NUSSLOCH
69226
GERMANY