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Recall Observatory FDA recall evidence

Device product

Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

Z-2177-2013

December 18, 2012

Class II

Product summary

Firm
Leica Microsystems (Schweiz) Ag
Event
Event 64601
Status
Terminated
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-2177-2013

Official wording

Reason: The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

Code information: Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312

Distribution pattern: Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The brake in the Z axis and/or brakes in the AB and C axes failed during installation.