Da Vinci Surgical Systems (2013-03-06)

Starting date:

March 6, 2013

Posting date:

March 18, 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-38235

• Reason
• Affected products

Recalled Products

Da Vinci  Surgical Systems

Reason

A revised instructions for use (IFU) for reprocessing of Da Vinci Endowrist Instruments will be released. These changes have been implemented to ensure customers have clear information related to the use and reprocessing of Da Vinci Instruments and accessories, and to assist Da Vinci customers with compliance to local requirements. The current IFU is still valid. This update improves the process, improves the clarity of the instructions themselves and allows for alkaline cleaners and is not being performed for safety issues or the IFU is defective.

Affected products