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

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  Reason
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  Affected products

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