Z-1042-2012

Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control...

Name: Z-1042-2012 Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control...
Creator: Leica Microsystems, Inc.
Published: 2011-12-21
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2011-12-21 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination... on 2011-12-21. The reason FDA records is "Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use". 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-1042-2012
Status: Terminated
Initiated: 2011-12-21
Posted: 2012-02-16
Terminated: 2012-02-16
Recalling firm: Leica Microsystems, Inc.
Product: Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Product code: ETP Stimulator, Caloric-Water
Reason for recall: Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to [email protected]. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade. If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.
Quantity in commerce: 29 units (10 units-USA)
Distribution: Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.
Product codes and lots: Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G

Product code ETP

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)