LEEP PRECISION Integrated System and Generator 2019-06-02)

Starting date:

June 2, 2019

Posting date:

June 14, 2019

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-70215

Last updated: 2019-06-14

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  Reason
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  Affected products

Affected Products

A. LEEP PRECISION Integrated System

B. LEEP PRECISION Generator

Reason

CooperSurgical is conducting a medical device safety alert for five (5) LEEP PRECISION Integrated System and generator units distributed to Canada (358 total units distributed) because of the possibility that the generator may lose power intermittently when using the foot pedal.  The LEEP PRECISION Integrated System unit will then cease to cut, coagulate, or blend tissue during a procedure.

Affected products