Z-1269-2012

Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the...

Name: Z-1269-2012 Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the...
Creator: Leica Microsystems, Inc.
Published: 2012-02-27
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-02-27 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article... on 2012-02-27. The reason FDA records is "The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling". 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-1269-2012
Status: Terminated
Initiated: 2012-02-27
Posted: 2012-03-21
Terminated: 2012-05-18
Recalling firm: Leica Microsystems, Inc.
Product: Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; 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: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Leica Microsystems, sent a "Medical Device Correction" letter dated February 27, 2012 to the affected customers via e-mail on the same date. The letter described the product, problem and action to be taken. The customers were informed that the Leica M820 and M844 C19 surgical microscopes require upgrading. An upgrade kit will be provide for replacement of the flange and axis of the touch panel/control unit carrier. The Customers were instructed to NOT USE the affected Leica surgical microscope until the unit has been upgraded by their Leica Microsystems representative and to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the serial numbers of the unit at their facility and fax it back to Leica at 1-847-236-3747. If they have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.
Quantity in commerce: 33 units
Distribution: Worldwide distribution: USA (nationwide) including states of: California, Connecticut, Kansas, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas and Utah; and countries of: Japan and South Africa,
Product codes and lots: article 10448196: serial numbers 17091004, 20911002, 26110801, 31207001, 31207002, 61006001, 61006002, 91208002, 101208001, 101210002, 140508002, 151209002, 160806002, 260811001, 261108001 and 261108002; article 10448197: serial numbers 11010001, 50510002, 81007003, 110507002, 130707001, 130707003, 160910008, 180607001, 230909001, 270407006 and 300307001

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)