Z-2053-2012Class II

Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max...

Name: Z-2053-2012 Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max...
Creator: Leica Microsystems, Inc.
Published: 2012-06-04
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-06-04 / Terminated / root cause: software

FDA source

Leica Microsystems, Inc. began a recall of Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage... on 2012-06-04. FDA classified it as Class II and gives the reason as "Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2053-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-04
Posted: 2012-07-20
Terminated: 2012-10-29
Recalling firm: Leica Microsystems, Inc.
Product: Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
Root cause tag: software
FDA root cause: Software design
Action: Leica Microsystems sent an Urgent Medical Device letter dated June 4, 2012 to the affected customers. The letter described the product, problem and actions to be taken. The customers were informed that the Leica surgical microscope M525 F50 required a software upgrade. Customers were instructed to NOT USE a remote video adapter or motorized video adapter until the required software upgrade has been installed by their Leica Microsystems representative. The customers were requested to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the serial numbers of the units at their facilities and to fax it back to Leica Microsystems at (847) 236-3747.
Quantity in commerce: 39 Units - USA , 4 Units - Canada
Distribution: Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.
Product codes and lots: Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311002, 90611001, 260711001, 20911001, 200911001, 210911001, 111011001, 141011001, 241011001, 121211001, 141211001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 90811001, 200312001, 50412001, 110112002, 280611001, 241011002, 20312001, 101011001 and 270911001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)