Leica M525 F50 Surgical Microscopes (2013-11-18)

Starting date:

November 18, 2013

Posting date:

February 10, 2014

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-37815

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  Reason
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  Affected products

Recalled Products

Leica M525 F50 Surgical Microscopes

Reason

Leica Microsystems (Schweiz) Ag evaluated data of an internal report showing, that it is possible an unspecified behaviour of the optional XY-unit for the Leica M525 F50 and Leica M525 C50. To date have not received any customer complaints involving a malfunction in the XY-unit. By moving the XY-joysticks of the handle or the footswitch diagonally it is possible that the XY-unit will unintentionally proceed in one direction until the end stop is reached. Consecutive entries in diagonal direction will contribute to the probability to stipulate this problem. After the XY movement is stopped by end stop or interruption through orthogonal XY-joystick command the XY-unit can be operated normally.

Affected products