Diode Laser WOLF 445 nm (2019-03-27)

Starting date:

March 27, 2019

Posting date:

April 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-69568

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

Diode Laser WOLF 445 nm

Reason

A software bug was detected by the manufacturer's engineering; it may cause higher power output than the one shown on the unit's screen. It is rare and can only happen if the user deliberately uses a shortcut to adjust the power (instead of using the "+" and "-" icons) along with a specific combination of 4 unique laser parameters (which is a again a rare combination). The laser has been in use worldwide for 2 years and no one to date has encountered this.

Affected products