The Recall Desk
HighFDA (Devices)·Z-2177-2013·Announced 2013-09-18

Leica Surgical Microscope Recall Due to Axis Brake Failure

Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure (brake failure) in a medical device used for human and veterinary treatment, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Leica Microsystems (Schweiz) Ag is recalling 28 units of surgical microscopes. 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.

The recall was initiated because the brake in the Z axis and/or brakes in the AB and C axes failed during installation. The affected units were distributed worldwide, including in the United States (nationwide, specifically in AK, CA, CO, NY, and OR) and in Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Leica Microsystems for further instructions on how to proceed with the recall.

The recalled product

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.
Manufacturer
Leica Microsystems (Schweiz) Ag
Category
Medical Device — Surgical Microscope
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Leica Microsystems (Schweiz) Ag under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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