CARLO EP (2019-01-23)

Starting date:

January 23, 2019

Posting date:

April 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69470

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

CARLO EP

Reason

BEKA Hospitec has received a very small number of cases reporting that the screw connection of the disc of a few lifts has become loose, as a result of which the screw could break.  However, in all known cases, the loosening of the screw connection and the resulting improper functioning of the product was caused by at least one element of inappropriate use (i.e. the use of the products contrary to their designated use or the user manual). BEKA Hospitec has investigated and has concluded that in case of inappropriate use, there is a small risk of detachment of the screw connection. The investigation furthermore has shown that the mechanically fixed screw connection could become loose, when the lift is moved by pulling the sling/ hanger bar bracket. If the bracket is pulled multiple times or repeatedly, the screw could be damaged due to material overstretching, thus causing the (possible) fall of the person installed in the sling which is fixed to the suspension device.

Affected products