Device recall: Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and c
Leica Microsystems (Schweiz) Ag (Heerbrugg, N/A) initiated this device recall on 18 Dec 2012; FDA lists 2 product records under event 64601, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 24 Apr 2017. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Leica Microsystems (Schweiz) Ag.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Leica Microsystems (Schweiz) Ag, Heerbrugg, N/A, Switzerland.
Reason for recall
"The brake in the Z axis and/or brakes in the AB and C axes failed during installation."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2176-2013 | 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. | 5 units | Class II | Terminated | 18 Sep 2013 |
| Z-2177-2013 | 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. | 28 units | Class II | Terminated | 18 Sep 2013 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The brake in the Z axis and/or brakes in the AB and C axes failed during installation."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.