ASP200S/ASP300S TISSUE PROCESSOR(2015-08-05)

Starting date:

August 5, 2015

Posting date:

August 24, 2015

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-54762

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  Reason
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  Affected products

Affected Products

A. ASP200S/ASP300S TISSUE PROCESSOR

Reason

One complaint was received where the remote alarm of an affected instrument did not alert the customer properly of an error that occurred during processing. A review meeting was held by the manufacturer to determine that the drawing of the remote alarm cable does have an error which led to a malfunction of the remote alarm. Cables with this error were used since April 24, 2013 in production. A ship hold of the ASP200s/ASP300s was initiated on July 13, 2015. Within this time period 901 instruments were distributed globally with the affected cables. The affected devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.

Affected products