Z-2177-2013Class II

Surgical microscope The device is used to improve the visibility of objects through magnification and...

Name: Z-2177-2013 Surgical microscope The device is used to improve the visibility of objects through magnification and...
Creator: Leica Microsystems (Schweiz) Ag
Published: 2012-12-18
License: https://open.fda.gov/license/

Leica Microsystems (Schweiz) AG / initiated 2012-12-18 / Terminated / root cause: design

FDA source

Leica Microsystems (Schweiz) Ag began a recall of Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and... on 2012-12-18. FDA classified it as Class II and gives the reason as "The brake in the Z axis and/or brakes in the AB and C axes failed during installation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2177-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-18
Posted: 2013-09-10
Terminated: 2017-04-24
Recalling firm: Leica Microsystems (Schweiz) AG
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.
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at [email protected] or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.
Quantity in commerce: 28 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2177-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2176-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2177-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)