Neuro-Fiberscope (2019-08-23)

Starting date:

August 23, 2019

Posting date:

September 12, 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-70961

Last updated: 2019-09-12

• Reason
• Affected products

Affected Products

Neuro-Fiberscope

Reason

During a complaint investigation the device instruction manual was reviewed and an error was noticed. For Steris SS1 E process, the quick connector kit model number and the associated tray number listed in the manual were incorrect. A further step was taken to review all flexible scope instruction manuals and found the error in other manuals as well.

Affected products