Recall Z-1269-2012 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems, Inc.
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 i
| Date | Mar 21, 2012 (initiated Feb 27, 2012) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.