INNOVA E4 Washer-Disinfector (2014-12-02)

Starting date:

December 2, 2014

Posting date:

December 15, 2014

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-42863

• Reason
• Affected products

Recalled Products

INNOVA E4 Washer-Disinfector

Reason

The products affected by this recall are the INNOVA E4 Washer-Disinfectors manufactured by SciCan GmbH. This recall is being initiated as a result of a recent service of 4 units at one location which identified that the insert spacer on the lower loading rack of the trolley had come off 3 of the 4 units. This insert spacer is located on the trolley where flexible scopes are loaded. When this trolley is inserted into the unit, this component slides a mechanism aside that blocks the flow of water and chemical when the trolley is not in place. Without this component in place there is nothing to slide the mechanism aside and therefore no flow of chemical to reprocess the scope. While there have been no other reports of this nature, it was imperative that all INNOVA E4 units be inspected to ensure that the fitting is securely in place.

Affected products