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